Surgery Trials
Surgery Trials
Surgery Trials
When thinking about interventional clinical trials, most people visualize patients receiving infusions or taking pills of an experimental drug. In addition, more often, those patients that will undergo surgery as standard of care will not consider that a trial has anything to offer them in that scenario.
However, surgery is sometimes part of a clinical trial. For example, an experimental drug or vaccine may be given before surgery, to create better conditions for the resection. In other cases, the patient may receive immunotherapy after surgery, to prevent recurrence of the cancer. Also, some trials offer the chance of experimenting with novel resection techniques at the moment of undergoing that surgery that is indicated by the standard of care.
Surgery is often a window of opportunity for participating in certain clinical trials.
Highlights of the ERASur trial:
- Who: Stage IV patients, MSS, BRAF wildtype, no liver-only metastases or mets to the peritoneum or omentum.
- What: Comparing outcomes of patients with ablative therapies + systemic therapy to systemic therapy only
- When: Active since 2023
- Where: 100 locations nationwide, additional locations added monthly
- Why: To improve overall survival for patients with limited metastatic disease
More Fight CRC Resources
NEW-COMET
Ablation vs. Resection of Colorectal Cancer Liver Metastases (NEW-COMET)
This trial for patients with colorectal cancer liver metastases will have 230 participants randomly assigned to resection or thermal ablation (microwave or radiofrequency ablation). As ablation becomes more frequently used to treat liver mets, this randomized trial looks at ablation versus resection and aims to get over selection bias as is seen commonly when ablation is used outside of a clinical trial setting.
The primary objective of this randomized, controlled, multicenter, double-blinded non-inferiority trial is to compare rates of local recurrence of cancer at 12 months. Secondary endpoints include overall survival, disease free survival, health-related quality of life, postoperative pain, complications, hospital stay, and cost-effectiveness.
The list of inclusion and exclusion criteria are given at the link above. Exclusion criteria include more than three lung mets and mets outside the lung and liver. Inclusion criteria include less than five tumors to be treated in one procedure and the size of the largest lesion not more than 30mm.
Pembrolizumab and Vactosertib on Liver Mets
Pembrolizumab After Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and Who Are Undergoing Liver Surgery
This single arm, open label, 19 participant Phase 2 trial, studies how well pembrolizumab and vactosertib work after standard of care chemotherapy in patients with colorectal cancer who have resectable liver mets. This trial uses pembrolizumab, an immunotherapy, and vactosertib, a drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. These drugs given after standard of care chemotherapy, but before liver metastases surgery, may help shrink the cancer prior to surgery. These drugs, when given after liver mets surgery, may decrease the risk of cancer coming back.
The primary outcome measure is to look at the proportion of patients with twofold or more increase in the number of tumor-infiltrating immune cells (TIICs) in pre- and post-pembrolizumab treatment tumor specimens. Several secondary outcome measures including objective response rate, effect on surgery, etc. will also be assessed.
Eligible patients include those with metastatic measurable confirmed resectable microsatellite stable colorectal cancer liver mets. Participants may have mets in other locations as well, if other eligibility criteria are met.
What treatments are being compared in the ERASur study?
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged.Lorem Ipsum passages, and more recently with desktop publishing software like Aldu PageMaker including versions of Lorem Ipsum.
What are the expected outcomes or endpoints being measured in the ERASur study?
Dr. Miller: The primary endpoint in the study is overall survival – comparing patients in the TAT group to those in the systemic therapy alone arm. We have additional secondary endpoints of event-free survival, toxicity of the treatments, and local control of metastatic disease in patients treated with TAT. Of note, we also have an optional blood collection in the study with planned future ctDNA analysis.
How does the trial address patient participation barriers?
Dr. Miller: Leaving as many decisions as possible to the treatment team and patient is one of the ways that we have made this trial pragmatic. We also permit patients to receive systemic therapy closer to their home and not necessarily at the site where they register for the trial which helps make participation in the trial much more feasible for patients who don’t live close to a site where the trial is open. I want to acknowledge the outstanding input from Manju and her colleagues from COLONTOWN for their input in making this truly a pragmatic trial.
To continue learning about the ERASur trial, check this X (Twitter) thread by @CrcTrialsChat, with short videos with the three Principal Investigators, and also this DocTalk of Manju with them, posted on Colontown University. You can also view this clinical trial in Fight CRC’s Clinical Trial Finder.
Acknowledgements: The PIs of the ERASur trial: Dr. Eric Miller, GI radiation oncologist and member of the Translational Therapeutics Program at the Ohio State University Comprehensive Cancer Center –James; Dr. Paul Romesser, radiation oncologist and early drug development specialist, director of Colorectal and Anal Cancer, Department of Radiation Oncology, at the Memorial Sloan Kettering Cancer Center, New York; and Dr. Kate Hitchcock, Clinical Associate Professor, Department of Radiation Oncology, University of Florida Health Cancer Center.
Stay Tuned
Once a month, Maia Walker and Manju George spend time unpacking important research trials, tips, and advice for our community. Be sure to subscribe to sign up with Fight CRC and join COLONTOWN’s online community to continue receiving the most relevant updates in the CRC world!
You can also follow Maia (@sassycell) and Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov for more information on trials.
When thinking about interventional clinical trials, most people visualize patients receiving infusions or taking pills of an experimental drug. In addition, more often, those patients that will undergo surgery as standard of care will not consider that a trial has anything to offer them in that scenario.
However, surgery is sometimes part of a clinical trial. For example, an experimental drug or vaccine may be given before surgery, to create better conditions for the resection. In other cases, the patient may receive immunotherapy after surgery, to prevent recurrence of the cancer. Also, some trials offer the chance of experimenting with novel resection techniques at the moment of undergoing that surgery that is indicated by the standard of care.
Surgery is often a window of opportunity for participating in certain clinical trials.
Highlights of the ERASur trial:
- Who: Stage IV patients, MSS, BRAF wildtype, no liver-only metastases or mets to the peritoneum or omentum.
- What: Comparing outcomes of patients with ablative therapies + systemic therapy to systemic therapy only
- When: Active since 2023
- Where: 100 locations nationwide, additional locations added monthly
- Why: To improve overall survival for patients with limited metastatic disease
More Fight CRC Resources
NEW-COMET
Ablation vs. Resection of Colorectal Cancer Liver Metastases (NEW-COMET)
This trial for patients with colorectal cancer liver metastases will have 230 participants randomly assigned to resection or thermal ablation (microwave or radiofrequency ablation). As ablation becomes more frequently used to treat liver mets, this randomized trial looks at ablation versus resection and aims to get over selection bias as is seen commonly when ablation is used outside of a clinical trial setting.
The primary objective of this randomized, controlled, multicenter, double-blinded non-inferiority trial is to compare rates of local recurrence of cancer at 12 months. Secondary endpoints include overall survival, disease free survival, health-related quality of life, postoperative pain, complications, hospital stay, and cost-effectiveness.
The list of inclusion and exclusion criteria are given at the link above. Exclusion criteria include more than three lung mets and mets outside the lung and liver. Inclusion criteria include less than five tumors to be treated in one procedure and the size of the largest lesion not more than 30mm.
Pembrolizumab and Vactosertib on Liver Mets
Pembrolizumab After Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and Who Are Undergoing Liver Surgery
This single arm, open label, 19 participant Phase 2 trial, studies how well pembrolizumab and vactosertib work after standard of care chemotherapy in patients with colorectal cancer who have resectable liver mets. This trial uses pembrolizumab, an immunotherapy, and vactosertib, a drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. These drugs given after standard of care chemotherapy, but before liver metastases surgery, may help shrink the cancer prior to surgery. These drugs, when given after liver mets surgery, may decrease the risk of cancer coming back.
The primary outcome measure is to look at the proportion of patients with twofold or more increase in the number of tumor-infiltrating immune cells (TIICs) in pre- and post-pembrolizumab treatment tumor specimens. Several secondary outcome measures including objective response rate, effect on surgery, etc. will also be assessed.
Eligible patients include those with metastatic measurable confirmed resectable microsatellite stable colorectal cancer liver mets. Participants may have mets in other locations as well, if other eligibility criteria are met.
What treatments are being compared in the ERASur study?
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged.Lorem Ipsum passages, and more recently with desktop publishing software like Aldu PageMaker including versions of Lorem Ipsum.
What are the expected outcomes or endpoints being measured in the ERASur study?
Dr. Miller: The primary endpoint in the study is overall survival – comparing patients in the TAT group to those in the systemic therapy alone arm. We have additional secondary endpoints of event-free survival, toxicity of the treatments, and local control of metastatic disease in patients treated with TAT. Of note, we also have an optional blood collection in the study with planned future ctDNA analysis.
How does the trial address patient participation barriers?
Dr. Miller: Leaving as many decisions as possible to the treatment team and patient is one of the ways that we have made this trial pragmatic. We also permit patients to receive systemic therapy closer to their home and not necessarily at the site where they register for the trial which helps make participation in the trial much more feasible for patients who don’t live close to a site where the trial is open. I want to acknowledge the outstanding input from Manju and her colleagues from COLONTOWN for their input in making this truly a pragmatic trial.
To continue learning about the ERASur trial, check this X (Twitter) thread by @CrcTrialsChat, with short videos with the three Principal Investigators, and also this DocTalk of Manju with them, posted on Colontown University. You can also view this clinical trial in Fight CRC’s Clinical Trial Finder.
Acknowledgements: The PIs of the ERASur trial: Dr. Eric Miller, GI radiation oncologist and member of the Translational Therapeutics Program at the Ohio State University Comprehensive Cancer Center –James; Dr. Paul Romesser, radiation oncologist and early drug development specialist, director of Colorectal and Anal Cancer, Department of Radiation Oncology, at the Memorial Sloan Kettering Cancer Center, New York; and Dr. Kate Hitchcock, Clinical Associate Professor, Department of Radiation Oncology, University of Florida Health Cancer Center.
Stay Tuned
Once a month, Maia Walker and Manju George spend time unpacking important research trials, tips, and advice for our community. Be sure to subscribe to sign up with Fight CRC and join COLONTOWN’s online community to continue receiving the most relevant updates in the CRC world!
You can also follow Maia (@sassycell) and Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov for more information on trials.
When thinking about interventional clinical trials, most people visualize patients receiving infusions or taking pills of an experimental drug. In addition, more often, those patients that will undergo surgery as standard of care will not consider that a trial has anything to offer them in that scenario.
However, surgery is sometimes part of a clinical trial. For example, an experimental drug or vaccine may be given before surgery, to create better conditions for the resection. In other cases, the patient may receive immunotherapy after surgery, to prevent recurrence of the cancer. Also, some trials offer the chance of experimenting with novel resection techniques at the moment of undergoing that surgery that is indicated by the standard of care.
Surgery is often a window of opportunity for participating in certain clinical trials.
Highlights of the ERASur trial:
- Who: Stage IV patients, MSS, BRAF wildtype, no liver-only metastases or mets to the peritoneum or omentum.
- What: Comparing outcomes of patients with ablative therapies + systemic therapy to systemic therapy only
- When: Active since 2023
- Where: 100 locations nationwide, additional locations added monthly
- Why: To improve overall survival for patients with limited metastatic disease
More Fight CRC Resources
NEW-COMET
Ablation vs. Resection of Colorectal Cancer Liver Metastases (NEW-COMET)
This trial for patients with colorectal cancer liver metastases will have 230 participants randomly assigned to resection or thermal ablation (microwave or radiofrequency ablation). As ablation becomes more frequently used to treat liver mets, this randomized trial looks at ablation versus resection and aims to get over selection bias as is seen commonly when ablation is used outside of a clinical trial setting.
The primary objective of this randomized, controlled, multicenter, double-blinded non-inferiority trial is to compare rates of local recurrence of cancer at 12 months. Secondary endpoints include overall survival, disease free survival, health-related quality of life, postoperative pain, complications, hospital stay, and cost-effectiveness.
The list of inclusion and exclusion criteria are given at the link above. Exclusion criteria include more than three lung mets and mets outside the lung and liver. Inclusion criteria include less than five tumors to be treated in one procedure and the size of the largest lesion not more than 30mm.
Pembrolizumab and Vactosertib on Liver Mets
Pembrolizumab After Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and Who Are Undergoing Liver Surgery
This single arm, open label, 19 participant Phase 2 trial, studies how well pembrolizumab and vactosertib work after standard of care chemotherapy in patients with colorectal cancer who have resectable liver mets. This trial uses pembrolizumab, an immunotherapy, and vactosertib, a drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. These drugs given after standard of care chemotherapy, but before liver metastases surgery, may help shrink the cancer prior to surgery. These drugs, when given after liver mets surgery, may decrease the risk of cancer coming back.
The primary outcome measure is to look at the proportion of patients with twofold or more increase in the number of tumor-infiltrating immune cells (TIICs) in pre- and post-pembrolizumab treatment tumor specimens. Several secondary outcome measures including objective response rate, effect on surgery, etc. will also be assessed.
Eligible patients include those with metastatic measurable confirmed resectable microsatellite stable colorectal cancer liver mets. Participants may have mets in other locations as well, if other eligibility criteria are met.
What treatments are being compared in the ERASur study?
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged.Lorem Ipsum passages, and more recently with desktop publishing software like Aldu PageMaker including versions of Lorem Ipsum.
What are the expected outcomes or endpoints being measured in the ERASur study?
Dr. Miller: The primary endpoint in the study is overall survival – comparing patients in the TAT group to those in the systemic therapy alone arm. We have additional secondary endpoints of event-free survival, toxicity of the treatments, and local control of metastatic disease in patients treated with TAT. Of note, we also have an optional blood collection in the study with planned future ctDNA analysis.
How does the trial address patient participation barriers?
Dr. Miller: Leaving as many decisions as possible to the treatment team and patient is one of the ways that we have made this trial pragmatic. We also permit patients to receive systemic therapy closer to their home and not necessarily at the site where they register for the trial which helps make participation in the trial much more feasible for patients who don’t live close to a site where the trial is open. I want to acknowledge the outstanding input from Manju and her colleagues from COLONTOWN for their input in making this truly a pragmatic trial.
To continue learning about the ERASur trial, check this X (Twitter) thread by @CrcTrialsChat, with short videos with the three Principal Investigators, and also this DocTalk of Manju with them, posted on Colontown University. You can also view this clinical trial in Fight CRC’s Clinical Trial Finder.
Acknowledgements: The PIs of the ERASur trial: Dr. Eric Miller, GI radiation oncologist and member of the Translational Therapeutics Program at the Ohio State University Comprehensive Cancer Center –James; Dr. Paul Romesser, radiation oncologist and early drug development specialist, director of Colorectal and Anal Cancer, Department of Radiation Oncology, at the Memorial Sloan Kettering Cancer Center, New York; and Dr. Kate Hitchcock, Clinical Associate Professor, Department of Radiation Oncology, University of Florida Health Cancer Center.
Stay Tuned
Once a month, Maia Walker and Manju George spend time unpacking important research trials, tips, and advice for our community. Be sure to subscribe to sign up with Fight CRC and join COLONTOWN’s online community to continue receiving the most relevant updates in the CRC world!
You can also follow Maia (@sassycell) and Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov for more information on trials.
When thinking about interventional clinical trials, most people visualize patients receiving infusions or taking pills of an experimental drug. In addition, more often, those patients that will undergo surgery as standard of care will not consider that a trial has anything to offer them in that scenario.
However, surgery is sometimes part of a clinical trial. For example, an experimental drug or vaccine may be given before surgery, to create better conditions for the resection. In other cases, the patient may receive immunotherapy after surgery, to prevent recurrence of the cancer. Also, some trials offer the chance of experimenting with novel resection techniques at the moment of undergoing that surgery that is indicated by the standard of care.
Surgery is often a window of opportunity for participating in certain clinical trials.
Highlights of the ERASur trial:
- Who: Stage IV patients, MSS, BRAF wildtype, no liver-only metastases or mets to the peritoneum or omentum.
- What: Comparing outcomes of patients with ablative therapies + systemic therapy to systemic therapy only
- When: Active since 2023
- Where: 100 locations nationwide, additional locations added monthly
- Why: To improve overall survival for patients with limited metastatic disease
More Fight CRC Resources
NEW-COMET
Ablation vs. Resection of Colorectal Cancer Liver Metastases (NEW-COMET)
This trial for patients with colorectal cancer liver metastases will have 230 participants randomly assigned to resection or thermal ablation (microwave or radiofrequency ablation). As ablation becomes more frequently used to treat liver mets, this randomized trial looks at ablation versus resection and aims to get over selection bias as is seen commonly when ablation is used outside of a clinical trial setting.
The primary objective of this randomized, controlled, multicenter, double-blinded non-inferiority trial is to compare rates of local recurrence of cancer at 12 months. Secondary endpoints include overall survival, disease free survival, health-related quality of life, postoperative pain, complications, hospital stay, and cost-effectiveness.
The list of inclusion and exclusion criteria are given at the link above. Exclusion criteria include more than three lung mets and mets outside the lung and liver. Inclusion criteria include less than five tumors to be treated in one procedure and the size of the largest lesion not more than 30mm.
Pembrolizumab and Vactosertib on Liver Mets
Pembrolizumab After Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and Who Are Undergoing Liver Surgery
This single arm, open label, 19 participant Phase 2 trial, studies how well pembrolizumab and vactosertib work after standard of care chemotherapy in patients with colorectal cancer who have resectable liver mets. This trial uses pembrolizumab, an immunotherapy, and vactosertib, a drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. These drugs given after standard of care chemotherapy, but before liver metastases surgery, may help shrink the cancer prior to surgery. These drugs, when given after liver mets surgery, may decrease the risk of cancer coming back.
The primary outcome measure is to look at the proportion of patients with twofold or more increase in the number of tumor-infiltrating immune cells (TIICs) in pre- and post-pembrolizumab treatment tumor specimens. Several secondary outcome measures including objective response rate, effect on surgery, etc. will also be assessed.
Eligible patients include those with metastatic measurable confirmed resectable microsatellite stable colorectal cancer liver mets. Participants may have mets in other locations as well, if other eligibility criteria are met.
What treatments are being compared in the ERASur study?
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged.Lorem Ipsum passages, and more recently with desktop publishing software like Aldu PageMaker including versions of Lorem Ipsum.
What are the expected outcomes or endpoints being measured in the ERASur study?
Dr. Miller: The primary endpoint in the study is overall survival – comparing patients in the TAT group to those in the systemic therapy alone arm. We have additional secondary endpoints of event-free survival, toxicity of the treatments, and local control of metastatic disease in patients treated with TAT. Of note, we also have an optional blood collection in the study with planned future ctDNA analysis.
How does the trial address patient participation barriers?
Dr. Miller: Leaving as many decisions as possible to the treatment team and patient is one of the ways that we have made this trial pragmatic. We also permit patients to receive systemic therapy closer to their home and not necessarily at the site where they register for the trial which helps make participation in the trial much more feasible for patients who don’t live close to a site where the trial is open. I want to acknowledge the outstanding input from Manju and her colleagues from COLONTOWN for their input in making this truly a pragmatic trial.
To continue learning about the ERASur trial, check this X (Twitter) thread by @CrcTrialsChat, with short videos with the three Principal Investigators, and also this DocTalk of Manju with them, posted on Colontown University. You can also view this clinical trial in Fight CRC’s Clinical Trial Finder.
Acknowledgements: The PIs of the ERASur trial: Dr. Eric Miller, GI radiation oncologist and member of the Translational Therapeutics Program at the Ohio State University Comprehensive Cancer Center –James; Dr. Paul Romesser, radiation oncologist and early drug development specialist, director of Colorectal and Anal Cancer, Department of Radiation Oncology, at the Memorial Sloan Kettering Cancer Center, New York; and Dr. Kate Hitchcock, Clinical Associate Professor, Department of Radiation Oncology, University of Florida Health Cancer Center.
Stay Tuned
Once a month, Maia Walker and Manju George spend time unpacking important research trials, tips, and advice for our community. Be sure to subscribe to sign up with Fight CRC and join COLONTOWN’s online community to continue receiving the most relevant updates in the CRC world!
You can also follow Maia (@sassycell) and Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov for more information on trials.
When thinking about interventional clinical trials, most people visualize patients receiving infusions or taking pills of an experimental drug. In addition, more often, those patients that will undergo surgery as standard of care will not consider that a trial has anything to offer them in that scenario.
However, surgery is sometimes part of a clinical trial. For example, an experimental drug or vaccine may be given before surgery, to create better conditions for the resection. In other cases, the patient may receive immunotherapy after surgery, to prevent recurrence of the cancer. Also, some trials offer the chance of experimenting with novel resection techniques at the moment of undergoing that surgery that is indicated by the standard of care.
Surgery is often a window of opportunity for participating in certain clinical trials.
Highlights of the ERASur trial:
- Who: Stage IV patients, MSS, BRAF wildtype, no liver-only metastases or mets to the peritoneum or omentum.
- What: Comparing outcomes of patients with ablative therapies + systemic therapy to systemic therapy only
- When: Active since 2023
- Where: 100 locations nationwide, additional locations added monthly
- Why: To improve overall survival for patients with limited metastatic disease
More Fight CRC Resources
NEW-COMET
Ablation vs. Resection of Colorectal Cancer Liver Metastases (NEW-COMET)
This trial for patients with colorectal cancer liver metastases will have 230 participants randomly assigned to resection or thermal ablation (microwave or radiofrequency ablation). As ablation becomes more frequently used to treat liver mets, this randomized trial looks at ablation versus resection and aims to get over selection bias as is seen commonly when ablation is used outside of a clinical trial setting.
The primary objective of this randomized, controlled, multicenter, double-blinded non-inferiority trial is to compare rates of local recurrence of cancer at 12 months. Secondary endpoints include overall survival, disease free survival, health-related quality of life, postoperative pain, complications, hospital stay, and cost-effectiveness.
The list of inclusion and exclusion criteria are given at the link above. Exclusion criteria include more than three lung mets and mets outside the lung and liver. Inclusion criteria include less than five tumors to be treated in one procedure and the size of the largest lesion not more than 30mm.
Pembrolizumab and Vactosertib on Liver Mets
Pembrolizumab After Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and Who Are Undergoing Liver Surgery
This single arm, open label, 19 participant Phase 2 trial, studies how well pembrolizumab and vactosertib work after standard of care chemotherapy in patients with colorectal cancer who have resectable liver mets. This trial uses pembrolizumab, an immunotherapy, and vactosertib, a drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. These drugs given after standard of care chemotherapy, but before liver metastases surgery, may help shrink the cancer prior to surgery. These drugs, when given after liver mets surgery, may decrease the risk of cancer coming back.
The primary outcome measure is to look at the proportion of patients with twofold or more increase in the number of tumor-infiltrating immune cells (TIICs) in pre- and post-pembrolizumab treatment tumor specimens. Several secondary outcome measures including objective response rate, effect on surgery, etc. will also be assessed.
Eligible patients include those with metastatic measurable confirmed resectable microsatellite stable colorectal cancer liver mets. Participants may have mets in other locations as well, if other eligibility criteria are met.
What treatments are being compared in the ERASur study?
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged.Lorem Ipsum passages, and more recently with desktop publishing software like Aldu PageMaker including versions of Lorem Ipsum.
What are the expected outcomes or endpoints being measured in the ERASur study?
Dr. Miller: The primary endpoint in the study is overall survival – comparing patients in the TAT group to those in the systemic therapy alone arm. We have additional secondary endpoints of event-free survival, toxicity of the treatments, and local control of metastatic disease in patients treated with TAT. Of note, we also have an optional blood collection in the study with planned future ctDNA analysis.
How does the trial address patient participation barriers?
Dr. Miller: Leaving as many decisions as possible to the treatment team and patient is one of the ways that we have made this trial pragmatic. We also permit patients to receive systemic therapy closer to their home and not necessarily at the site where they register for the trial which helps make participation in the trial much more feasible for patients who don’t live close to a site where the trial is open. I want to acknowledge the outstanding input from Manju and her colleagues from COLONTOWN for their input in making this truly a pragmatic trial.
To continue learning about the ERASur trial, check this X (Twitter) thread by @CrcTrialsChat, with short videos with the three Principal Investigators, and also this DocTalk of Manju with them, posted on Colontown University. You can also view this clinical trial in Fight CRC’s Clinical Trial Finder.
Acknowledgements: The PIs of the ERASur trial: Dr. Eric Miller, GI radiation oncologist and member of the Translational Therapeutics Program at the Ohio State University Comprehensive Cancer Center –James; Dr. Paul Romesser, radiation oncologist and early drug development specialist, director of Colorectal and Anal Cancer, Department of Radiation Oncology, at the Memorial Sloan Kettering Cancer Center, New York; and Dr. Kate Hitchcock, Clinical Associate Professor, Department of Radiation Oncology, University of Florida Health Cancer Center.
Stay Tuned
Once a month, Maia Walker and Manju George spend time unpacking important research trials, tips, and advice for our community. Be sure to subscribe to sign up with Fight CRC and join COLONTOWN’s online community to continue receiving the most relevant updates in the CRC world!
You can also follow Maia (@sassycell) and Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov for more information on trials.
When thinking about interventional clinical trials, most people visualize patients receiving infusions or taking pills of an experimental drug. In addition, more often, those patients that will undergo surgery as standard of care will not consider that a trial has anything to offer them in that scenario.
However, surgery is sometimes part of a clinical trial. For example, an experimental drug or vaccine may be given before surgery, to create better conditions for the resection. In other cases, the patient may receive immunotherapy after surgery, to prevent recurrence of the cancer. Also, some trials offer the chance of experimenting with novel resection techniques at the moment of undergoing that surgery that is indicated by the standard of care.
Surgery is often a window of opportunity for participating in certain clinical trials.
Highlights of the ERASur trial:
- Who: Stage IV patients, MSS, BRAF wildtype, no liver-only metastases or mets to the peritoneum or omentum.
- What: Comparing outcomes of patients with ablative therapies + systemic therapy to systemic therapy only
- When: Active since 2023
- Where: 100 locations nationwide, additional locations added monthly
- Why: To improve overall survival for patients with limited metastatic disease
More Fight CRC Resources
NEW-COMET
Ablation vs. Resection of Colorectal Cancer Liver Metastases (NEW-COMET)
This trial for patients with colorectal cancer liver metastases will have 230 participants randomly assigned to resection or thermal ablation (microwave or radiofrequency ablation). As ablation becomes more frequently used to treat liver mets, this randomized trial looks at ablation versus resection and aims to get over selection bias as is seen commonly when ablation is used outside of a clinical trial setting.
The primary objective of this randomized, controlled, multicenter, double-blinded non-inferiority trial is to compare rates of local recurrence of cancer at 12 months. Secondary endpoints include overall survival, disease free survival, health-related quality of life, postoperative pain, complications, hospital stay, and cost-effectiveness.
The list of inclusion and exclusion criteria are given at the link above. Exclusion criteria include more than three lung mets and mets outside the lung and liver. Inclusion criteria include less than five tumors to be treated in one procedure and the size of the largest lesion not more than 30mm.
Pembrolizumab and Vactosertib on Liver Mets
Pembrolizumab After Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and Who Are Undergoing Liver Surgery
This single arm, open label, 19 participant Phase 2 trial, studies how well pembrolizumab and vactosertib work after standard of care chemotherapy in patients with colorectal cancer who have resectable liver mets. This trial uses pembrolizumab, an immunotherapy, and vactosertib, a drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. These drugs given after standard of care chemotherapy, but before liver metastases surgery, may help shrink the cancer prior to surgery. These drugs, when given after liver mets surgery, may decrease the risk of cancer coming back.
The primary outcome measure is to look at the proportion of patients with twofold or more increase in the number of tumor-infiltrating immune cells (TIICs) in pre- and post-pembrolizumab treatment tumor specimens. Several secondary outcome measures including objective response rate, effect on surgery, etc. will also be assessed.
Eligible patients include those with metastatic measurable confirmed resectable microsatellite stable colorectal cancer liver mets. Participants may have mets in other locations as well, if other eligibility criteria are met.
What treatments are being compared in the ERASur study?
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged.Lorem Ipsum passages, and more recently with desktop publishing software like Aldu PageMaker including versions of Lorem Ipsum.
What are the expected outcomes or endpoints being measured in the ERASur study?
Dr. Miller: The primary endpoint in the study is overall survival – comparing patients in the TAT group to those in the systemic therapy alone arm. We have additional secondary endpoints of event-free survival, toxicity of the treatments, and local control of metastatic disease in patients treated with TAT. Of note, we also have an optional blood collection in the study with planned future ctDNA analysis.
How does the trial address patient participation barriers?
Dr. Miller: Leaving as many decisions as possible to the treatment team and patient is one of the ways that we have made this trial pragmatic. We also permit patients to receive systemic therapy closer to their home and not necessarily at the site where they register for the trial which helps make participation in the trial much more feasible for patients who don’t live close to a site where the trial is open. I want to acknowledge the outstanding input from Manju and her colleagues from COLONTOWN for their input in making this truly a pragmatic trial.
To continue learning about the ERASur trial, check this X (Twitter) thread by @CrcTrialsChat, with short videos with the three Principal Investigators, and also this DocTalk of Manju with them, posted on Colontown University. You can also view this clinical trial in Fight CRC’s Clinical Trial Finder.
Acknowledgements: The PIs of the ERASur trial: Dr. Eric Miller, GI radiation oncologist and member of the Translational Therapeutics Program at the Ohio State University Comprehensive Cancer Center –James; Dr. Paul Romesser, radiation oncologist and early drug development specialist, director of Colorectal and Anal Cancer, Department of Radiation Oncology, at the Memorial Sloan Kettering Cancer Center, New York; and Dr. Kate Hitchcock, Clinical Associate Professor, Department of Radiation Oncology, University of Florida Health Cancer Center.
Stay Tuned
Once a month, Maia Walker and Manju George spend time unpacking important research trials, tips, and advice for our community. Be sure to subscribe to sign up with Fight CRC and join COLONTOWN’s online community to continue receiving the most relevant updates in the CRC world!
You can also follow Maia (@sassycell) and Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov for more information on trials.
When thinking about interventional clinical trials, most people visualize patients receiving infusions or taking pills of an experimental drug. In addition, more often, those patients that will undergo surgery as standard of care will not consider that a trial has anything to offer them in that scenario.
However, surgery is sometimes part of a clinical trial. For example, an experimental drug or vaccine may be given before surgery, to create better conditions for the resection. In other cases, the patient may receive immunotherapy after surgery, to prevent recurrence of the cancer. Also, some trials offer the chance of experimenting with novel resection techniques at the moment of undergoing that surgery that is indicated by the standard of care.
Surgery is often a window of opportunity for participating in certain clinical trials.
Highlights of the ERASur trial:
- Who: Stage IV patients, MSS, BRAF wildtype, no liver-only metastases or mets to the peritoneum or omentum.
- What: Comparing outcomes of patients with ablative therapies + systemic therapy to systemic therapy only
- When: Active since 2023
- Where: 100 locations nationwide, additional locations added monthly
- Why: To improve overall survival for patients with limited metastatic disease
More Fight CRC Resources
NEW-COMET
Ablation vs. Resection of Colorectal Cancer Liver Metastases (NEW-COMET)
This trial for patients with colorectal cancer liver metastases will have 230 participants randomly assigned to resection or thermal ablation (microwave or radiofrequency ablation). As ablation becomes more frequently used to treat liver mets, this randomized trial looks at ablation versus resection and aims to get over selection bias as is seen commonly when ablation is used outside of a clinical trial setting.
The primary objective of this randomized, controlled, multicenter, double-blinded non-inferiority trial is to compare rates of local recurrence of cancer at 12 months. Secondary endpoints include overall survival, disease free survival, health-related quality of life, postoperative pain, complications, hospital stay, and cost-effectiveness.
The list of inclusion and exclusion criteria are given at the link above. Exclusion criteria include more than three lung mets and mets outside the lung and liver. Inclusion criteria include less than five tumors to be treated in one procedure and the size of the largest lesion not more than 30mm.
Pembrolizumab and Vactosertib on Liver Mets
Pembrolizumab After Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and Who Are Undergoing Liver Surgery
This single arm, open label, 19 participant Phase 2 trial, studies how well pembrolizumab and vactosertib work after standard of care chemotherapy in patients with colorectal cancer who have resectable liver mets. This trial uses pembrolizumab, an immunotherapy, and vactosertib, a drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. These drugs given after standard of care chemotherapy, but before liver metastases surgery, may help shrink the cancer prior to surgery. These drugs, when given after liver mets surgery, may decrease the risk of cancer coming back.
The primary outcome measure is to look at the proportion of patients with twofold or more increase in the number of tumor-infiltrating immune cells (TIICs) in pre- and post-pembrolizumab treatment tumor specimens. Several secondary outcome measures including objective response rate, effect on surgery, etc. will also be assessed.
Eligible patients include those with metastatic measurable confirmed resectable microsatellite stable colorectal cancer liver mets. Participants may have mets in other locations as well, if other eligibility criteria are met.
What treatments are being compared in the ERASur study?
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged.Lorem Ipsum passages, and more recently with desktop publishing software like Aldu PageMaker including versions of Lorem Ipsum.
What are the expected outcomes or endpoints being measured in the ERASur study?
Dr. Miller: The primary endpoint in the study is overall survival – comparing patients in the TAT group to those in the systemic therapy alone arm. We have additional secondary endpoints of event-free survival, toxicity of the treatments, and local control of metastatic disease in patients treated with TAT. Of note, we also have an optional blood collection in the study with planned future ctDNA analysis.
How does the trial address patient participation barriers?
Dr. Miller: Leaving as many decisions as possible to the treatment team and patient is one of the ways that we have made this trial pragmatic. We also permit patients to receive systemic therapy closer to their home and not necessarily at the site where they register for the trial which helps make participation in the trial much more feasible for patients who don’t live close to a site where the trial is open. I want to acknowledge the outstanding input from Manju and her colleagues from COLONTOWN for their input in making this truly a pragmatic trial.
To continue learning about the ERASur trial, check this X (Twitter) thread by @CrcTrialsChat, with short videos with the three Principal Investigators, and also this DocTalk of Manju with them, posted on Colontown University. You can also view this clinical trial in Fight CRC’s Clinical Trial Finder.
Acknowledgements: The PIs of the ERASur trial: Dr. Eric Miller, GI radiation oncologist and member of the Translational Therapeutics Program at the Ohio State University Comprehensive Cancer Center –James; Dr. Paul Romesser, radiation oncologist and early drug development specialist, director of Colorectal and Anal Cancer, Department of Radiation Oncology, at the Memorial Sloan Kettering Cancer Center, New York; and Dr. Kate Hitchcock, Clinical Associate Professor, Department of Radiation Oncology, University of Florida Health Cancer Center.
Stay Tuned
Once a month, Maia Walker and Manju George spend time unpacking important research trials, tips, and advice for our community. Be sure to subscribe to sign up with Fight CRC and join COLONTOWN’s online community to continue receiving the most relevant updates in the CRC world!
You can also follow Maia (@sassycell) and Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov for more information on trials.
When thinking about interventional clinical trials, most people visualize patients receiving infusions or taking pills of an experimental drug. In addition, more often, those patients that will undergo surgery as standard of care will not consider that a trial has anything to offer them in that scenario.
However, surgery is sometimes part of a clinical trial. For example, an experimental drug or vaccine may be given before surgery, to create better conditions for the resection. In other cases, the patient may receive immunotherapy after surgery, to prevent recurrence of the cancer. Also, some trials offer the chance of experimenting with novel resection techniques at the moment of undergoing that surgery that is indicated by the standard of care.
Surgery is often a window of opportunity for participating in certain clinical trials.
Highlights of the ERASur trial:
- Who: Stage IV patients, MSS, BRAF wildtype, no liver-only metastases or mets to the peritoneum or omentum.
- What: Comparing outcomes of patients with ablative therapies + systemic therapy to systemic therapy only
- When: Active since 2023
- Where: 100 locations nationwide, additional locations added monthly
- Why: To improve overall survival for patients with limited metastatic disease
More Fight CRC Resources
NEW-COMET
Ablation vs. Resection of Colorectal Cancer Liver Metastases (NEW-COMET)
This trial for patients with colorectal cancer liver metastases will have 230 participants randomly assigned to resection or thermal ablation (microwave or radiofrequency ablation). As ablation becomes more frequently used to treat liver mets, this randomized trial looks at ablation versus resection and aims to get over selection bias as is seen commonly when ablation is used outside of a clinical trial setting.
The primary objective of this randomized, controlled, multicenter, double-blinded non-inferiority trial is to compare rates of local recurrence of cancer at 12 months. Secondary endpoints include overall survival, disease free survival, health-related quality of life, postoperative pain, complications, hospital stay, and cost-effectiveness.
The list of inclusion and exclusion criteria are given at the link above. Exclusion criteria include more than three lung mets and mets outside the lung and liver. Inclusion criteria include less than five tumors to be treated in one procedure and the size of the largest lesion not more than 30mm.
Pembrolizumab and Vactosertib on Liver Mets
Pembrolizumab After Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and Who Are Undergoing Liver Surgery
This single arm, open label, 19 participant Phase 2 trial, studies how well pembrolizumab and vactosertib work after standard of care chemotherapy in patients with colorectal cancer who have resectable liver mets. This trial uses pembrolizumab, an immunotherapy, and vactosertib, a drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. These drugs given after standard of care chemotherapy, but before liver metastases surgery, may help shrink the cancer prior to surgery. These drugs, when given after liver mets surgery, may decrease the risk of cancer coming back.
The primary outcome measure is to look at the proportion of patients with twofold or more increase in the number of tumor-infiltrating immune cells (TIICs) in pre- and post-pembrolizumab treatment tumor specimens. Several secondary outcome measures including objective response rate, effect on surgery, etc. will also be assessed.
Eligible patients include those with metastatic measurable confirmed resectable microsatellite stable colorectal cancer liver mets. Participants may have mets in other locations as well, if other eligibility criteria are met.
What treatments are being compared in the ERASur study?
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged.Lorem Ipsum passages, and more recently with desktop publishing software like Aldu PageMaker including versions of Lorem Ipsum.
What are the expected outcomes or endpoints being measured in the ERASur study?
Dr. Miller: The primary endpoint in the study is overall survival – comparing patients in the TAT group to those in the systemic therapy alone arm. We have additional secondary endpoints of event-free survival, toxicity of the treatments, and local control of metastatic disease in patients treated with TAT. Of note, we also have an optional blood collection in the study with planned future ctDNA analysis.
How does the trial address patient participation barriers?
Dr. Miller: Leaving as many decisions as possible to the treatment team and patient is one of the ways that we have made this trial pragmatic. We also permit patients to receive systemic therapy closer to their home and not necessarily at the site where they register for the trial which helps make participation in the trial much more feasible for patients who don’t live close to a site where the trial is open. I want to acknowledge the outstanding input from Manju and her colleagues from COLONTOWN for their input in making this truly a pragmatic trial.
To continue learning about the ERASur trial, check this X (Twitter) thread by @CrcTrialsChat, with short videos with the three Principal Investigators, and also this DocTalk of Manju with them, posted on Colontown University. You can also view this clinical trial in Fight CRC’s Clinical Trial Finder.
Acknowledgements: The PIs of the ERASur trial: Dr. Eric Miller, GI radiation oncologist and member of the Translational Therapeutics Program at the Ohio State University Comprehensive Cancer Center –James; Dr. Paul Romesser, radiation oncologist and early drug development specialist, director of Colorectal and Anal Cancer, Department of Radiation Oncology, at the Memorial Sloan Kettering Cancer Center, New York; and Dr. Kate Hitchcock, Clinical Associate Professor, Department of Radiation Oncology, University of Florida Health Cancer Center.
Stay Tuned
Once a month, Maia Walker and Manju George spend time unpacking important research trials, tips, and advice for our community. Be sure to subscribe to sign up with Fight CRC and join COLONTOWN’s online community to continue receiving the most relevant updates in the CRC world!
You can also follow Maia (@sassycell) and Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov for more information on trials.
When thinking about interventional clinical trials, most people visualize patients receiving infusions or taking pills of an experimental drug. In addition, more often, those patients that will undergo surgery as standard of care will not consider that a trial has anything to offer them in that scenario.
However, surgery is sometimes part of a clinical trial. For example, an experimental drug or vaccine may be given before surgery, to create better conditions for the resection. In other cases, the patient may receive immunotherapy after surgery, to prevent recurrence of the cancer. Also, some trials offer the chance of experimenting with novel resection techniques at the moment of undergoing that surgery that is indicated by the standard of care.
Surgery is often a window of opportunity for participating in certain clinical trials.
Highlights of the ERASur trial:
- Who: Stage IV patients, MSS, BRAF wildtype, no liver-only metastases or mets to the peritoneum or omentum.
- What: Comparing outcomes of patients with ablative therapies + systemic therapy to systemic therapy only
- When: Active since 2023
- Where: 100 locations nationwide, additional locations added monthly
- Why: To improve overall survival for patients with limited metastatic disease
More Fight CRC Resources
NEW-COMET
Ablation vs. Resection of Colorectal Cancer Liver Metastases (NEW-COMET)
This trial for patients with colorectal cancer liver metastases will have 230 participants randomly assigned to resection or thermal ablation (microwave or radiofrequency ablation). As ablation becomes more frequently used to treat liver mets, this randomized trial looks at ablation versus resection and aims to get over selection bias as is seen commonly when ablation is used outside of a clinical trial setting.
The primary objective of this randomized, controlled, multicenter, double-blinded non-inferiority trial is to compare rates of local recurrence of cancer at 12 months. Secondary endpoints include overall survival, disease free survival, health-related quality of life, postoperative pain, complications, hospital stay, and cost-effectiveness.
The list of inclusion and exclusion criteria are given at the link above. Exclusion criteria include more than three lung mets and mets outside the lung and liver. Inclusion criteria include less than five tumors to be treated in one procedure and the size of the largest lesion not more than 30mm.
Pembrolizumab and Vactosertib on Liver Mets
Pembrolizumab After Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and Who Are Undergoing Liver Surgery
This single arm, open label, 19 participant Phase 2 trial, studies how well pembrolizumab and vactosertib work after standard of care chemotherapy in patients with colorectal cancer who have resectable liver mets. This trial uses pembrolizumab, an immunotherapy, and vactosertib, a drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. These drugs given after standard of care chemotherapy, but before liver metastases surgery, may help shrink the cancer prior to surgery. These drugs, when given after liver mets surgery, may decrease the risk of cancer coming back.
The primary outcome measure is to look at the proportion of patients with twofold or more increase in the number of tumor-infiltrating immune cells (TIICs) in pre- and post-pembrolizumab treatment tumor specimens. Several secondary outcome measures including objective response rate, effect on surgery, etc. will also be assessed.
Eligible patients include those with metastatic measurable confirmed resectable microsatellite stable colorectal cancer liver mets. Participants may have mets in other locations as well, if other eligibility criteria are met.
What treatments are being compared in the ERASur study?
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged.Lorem Ipsum passages, and more recently with desktop publishing software like Aldu PageMaker including versions of Lorem Ipsum.
What are the expected outcomes or endpoints being measured in the ERASur study?
Dr. Miller: The primary endpoint in the study is overall survival – comparing patients in the TAT group to those in the systemic therapy alone arm. We have additional secondary endpoints of event-free survival, toxicity of the treatments, and local control of metastatic disease in patients treated with TAT. Of note, we also have an optional blood collection in the study with planned future ctDNA analysis.
How does the trial address patient participation barriers?
Dr. Miller: Leaving as many decisions as possible to the treatment team and patient is one of the ways that we have made this trial pragmatic. We also permit patients to receive systemic therapy closer to their home and not necessarily at the site where they register for the trial which helps make participation in the trial much more feasible for patients who don’t live close to a site where the trial is open. I want to acknowledge the outstanding input from Manju and her colleagues from COLONTOWN for their input in making this truly a pragmatic trial.
To continue learning about the ERASur trial, check this X (Twitter) thread by @CrcTrialsChat, with short videos with the three Principal Investigators, and also this DocTalk of Manju with them, posted on Colontown University. You can also view this clinical trial in Fight CRC’s Clinical Trial Finder.
Acknowledgements: The PIs of the ERASur trial: Dr. Eric Miller, GI radiation oncologist and member of the Translational Therapeutics Program at the Ohio State University Comprehensive Cancer Center –James; Dr. Paul Romesser, radiation oncologist and early drug development specialist, director of Colorectal and Anal Cancer, Department of Radiation Oncology, at the Memorial Sloan Kettering Cancer Center, New York; and Dr. Kate Hitchcock, Clinical Associate Professor, Department of Radiation Oncology, University of Florida Health Cancer Center.
Stay Tuned
Once a month, Maia Walker and Manju George spend time unpacking important research trials, tips, and advice for our community. Be sure to subscribe to sign up with Fight CRC and join COLONTOWN’s online community to continue receiving the most relevant updates in the CRC world!
You can also follow Maia (@sassycell) and Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov for more information on trials.
