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.
ERASur 试验的亮点
- 适用人群：IV 期患者，MSS，BRAF 野生型，无肝转移或腹膜或网膜转移。
- 内容： 比较采用消融疗法+全身疗法和仅采用全身疗法的患者的疗效
- 何时自 2023 年起活跃
- 地点全国 100 个地点，每月新增地点
- 原因： 提高局限性转移性疾病患者的总生存率
更多打击儿童权利委员会资源
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.
ERASur 研究比较了哪些治疗方法？
Lorem Ipsum 只是印刷和排版行业的假文本。自 1500 年代以来，Lorem Ipsum 一直是印刷业的标准虚拟文本。它不仅历经了五个世纪，而且在电子排版的飞跃中也保持了基本不变。20 世纪 60 年代，随着包含 Lorem Ipsum 段落的 Letraset 纸张的发布，以及最近 Aldus PageMaker 等桌面排版软件包含 Lorem Ipsum 版本，Lorem Ipsum 开始流行起来。
Lorem Ipsum 只是印刷和排版行业的假文本。自 1500 年代以来，Lorem Ipsum 一直是印刷业的标准虚拟文本。它不仅经历了五个世纪，而且在电子排版的飞跃中保持了基本不变。
ERASur 研究的预期结果或终点是什么？
米勒博士这项研究的主要终点是总生存期--比较 TAT 组和单纯系统治疗组患者的生存期。我们还有其他次要终点，包括无事件生存期、治疗毒性以及接受 TAT 治疗的患者转移性疾病的局部控制情况。值得注意的是，我们还将在研究中选择性地采集血液，并计划在未来进行ctDNA分析。
试验如何解决患者参与障碍？
米勒博士将尽可能多的决定权留给治疗团队和患者，是我们使这项试验实用化的方法之一。我们还允许患者在离家较近的地方接受系统治疗，而不一定是在他们登记参加试验的地点，这有助于让那些居住地离试验地点不近的患者更容易参加试验。我要感谢曼朱和她在 COLONTOWN 的同事们为使这项试验真正成为一项务实的试验所做出的杰出贡献。
要继续了解 ERASur 试验，请查看 @CrcTrialsChat 的 X（Twitter）主题，其中包含与三位首席研究员的视频短片，以及科伦镇大学发布的 Manju 与他们的 DocTalk。您还可以在 Fight CRC 的临床试验搜索器中查看该临床试验。
致谢：ERASur试验的首席研究员：俄亥俄州立大学詹姆斯综合癌症中心转化治疗项目成员、消化道放射肿瘤学家 Eric Miller 博士；纽约纪念斯隆凯特琳癌症中心放射肿瘤部结直肠癌和肛门癌主任、放射肿瘤学家、早期药物开发专家 Paul Romesser 博士；佛罗里达大学健康癌症中心放射肿瘤部临床副教授 Kate Hitchcock 博士。
敬请期待
每月一次，Maia Walker 和 Manju George 将为我们的社区解读重要的研究试验、提示和建议。请务必订阅并注册 Fight CRC，加入 COLONTOWN 的在线社区，继续接收 CRC 世界中最相关的最新信息！
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.
ERASur 试验的亮点
- 适用人群：IV 期患者，MSS，BRAF 野生型，无肝转移或腹膜或网膜转移。
- 内容： 比较采用消融疗法+全身疗法和仅采用全身疗法的患者的疗效
- 何时自 2023 年起活跃
- 地点全国 100 个地点，每月新增地点
- 原因： 提高局限性转移性疾病患者的总生存率
更多打击儿童权利委员会资源
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.
ERASur 研究比较了哪些治疗方法？
Lorem Ipsum 只是印刷和排版行业的假文本。自 1500 年代以来，Lorem Ipsum 一直是印刷业的标准虚拟文本。它不仅历经了五个世纪，而且在电子排版的飞跃中也保持了基本不变。20 世纪 60 年代，随着包含 Lorem Ipsum 段落的 Letraset 纸张的发布，以及最近 Aldus PageMaker 等桌面排版软件包含 Lorem Ipsum 版本，Lorem Ipsum 开始流行起来。
Lorem Ipsum 只是印刷和排版行业的假文本。自 1500 年代以来，Lorem Ipsum 一直是印刷业的标准虚拟文本。它不仅经历了五个世纪，而且在电子排版的飞跃中保持了基本不变。
ERASur 研究的预期结果或终点是什么？
米勒博士这项研究的主要终点是总生存期--比较 TAT 组和单纯系统治疗组患者的生存期。我们还有其他次要终点，包括无事件生存期、治疗毒性以及接受 TAT 治疗的患者转移性疾病的局部控制情况。值得注意的是，我们还将在研究中选择性地采集血液，并计划在未来进行ctDNA分析。
试验如何解决患者参与障碍？
米勒博士将尽可能多的决定权留给治疗团队和患者，是我们使这项试验实用化的方法之一。我们还允许患者在离家较近的地方接受系统治疗，而不一定是在他们登记参加试验的地点，这有助于让那些居住地离试验地点不近的患者更容易参加试验。我要感谢曼朱和她在 COLONTOWN 的同事们为使这项试验真正成为一项务实的试验所做出的杰出贡献。
要继续了解 ERASur 试验，请查看 @CrcTrialsChat 的 X（Twitter）主题，其中包含与三位首席研究员的视频短片，以及科伦镇大学发布的 Manju 与他们的 DocTalk。您还可以在 Fight CRC 的临床试验搜索器中查看该临床试验。
致谢：ERASur试验的首席研究员：俄亥俄州立大学詹姆斯综合癌症中心转化治疗项目成员、消化道放射肿瘤学家 Eric Miller 博士；纽约纪念斯隆凯特琳癌症中心放射肿瘤部结直肠癌和肛门癌主任、放射肿瘤学家、早期药物开发专家 Paul Romesser 博士；佛罗里达大学健康癌症中心放射肿瘤部临床副教授 Kate Hitchcock 博士。
敬请期待
每月一次，Maia Walker 和 Manju George 将为我们的社区解读重要的研究试验、提示和建议。请务必订阅并注册 Fight CRC，加入 COLONTOWN 的在线社区，继续接收 CRC 世界中最相关的最新信息！
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.
