A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Capecitabine Versus Bevacizumab Plus Capecitabine in Participants With Unresectable or Metastatic Colorectal Cancer

计划状态

活跃,非招募

阶段

第 1 阶段 第二阶段

允许先接受免疫治疗

没有

CRC 指导的试验

药物

Bevacizumab, capecitabine, LBL-007, Tislelizumab

标签

MSS/ MMRp

评论

For MSS CRC patients who are about to start first line of treatment in the metastatic setting (no prior chemo for metastatic cancer allowed). Patients with BRAF V600E mutated cancer are excluded from participation.
Standard of care (bevacizumab +  fluoropyrimidine (5-FU or capecitabine)) vs different combinations/ different doses of two experimental agents, immunotherapies:
tislelizumab: anti PD-1, checkpoint inhbitor.
LBL-007: anti LAG-3 antibody (immunotherapy targeting human Lymphocyte-activation gene3 (LAG-3).

地点 位置状态
美国
Alaska Oncology and Hematology, Llc
阿拉斯加州安克拉治市 99508
活跃,非招募
Banner Md Anderson Cancer Center
亚利桑那州吉尔伯特 85234
活跃,非招募
Toi Clinical Research
Cerritos, California 90703
活跃,非招募
Usc Norris Comprehensive Cancer Center (Nccc)
加利福尼亚州洛杉矶 90033
活跃,非招募
Valkyrie 临床试验
加利福尼亚州洛杉矶 90067
活跃,非招募
加利福尼亚大学洛杉矶分校
加利福尼亚州洛杉矶 90095
活跃,非招募
Hoag Memorial Presbyterian
Newport, California 92663
活跃,非招募
Kaiser Permanente Northern California
Vallejo, California 94510
活跃,非招募
Baptist Md Anderson Cancer Center
Jacksonville, Florida 32207
活跃,非招募
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46804
活跃,非招募
Baptist Health Lexington
Lexington, Kentucky 40503
活跃,非招募
University of Kentucky Markey Cancer Center
肯塔基州列克星敦 40536
活跃,非招募
Norton Cancer Institute
Louisville, Kentucky 40217
活跃,非招募
Pontchartrain Cancer Center
Covington, Louisiana 70433
活跃,非招募
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
活跃,非招募
华盛顿大学医学院
St Louis, Missouri 63110
活跃,非招募
St Vincent Frontier Cancer Center
蒙大拿州比林斯 59102
活跃,非招募
内华达综合癌症中心
内华达州拉斯维加斯 89169
活跃,非招募
Cancer Care Specialists
Reno, Nevada 89511
活跃,非招募
新墨西哥大学癌症中心
Albuquerque, New Mexico 87102
活跃,非招募
Perlmutter Cancer Center At Winthrop Oncology Hematology Associatesnyu Winthrop Hospital
Mineola, New York 11501
活跃,非招募
Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health
纽约州纽约市 10016
活跃,非招募
Columbia University Medical Center
纽约州纽约市 10032
活跃,非招募
Duke Cancer Center
北卡罗来纳州达勒姆 27710
活跃,非招募
University of Tennessee Medical Center
Knoxville, Tennessee 37920
活跃,非招募
Ut Southwestern Medical Center
德克萨斯州达拉斯 75390
活跃,非招募
Ut Health San Antonio Mays Cancer Center
德克萨斯州圣安东尼奥 78229
活跃,非招募
弗吉尼亚癌症专科
弗吉尼亚州费尔法克斯 22031
活跃,非招募
Cancer Care Northwest
Spokane Valley, Washington 99216
活跃,非招募
Multicare Health System Institute For Research and Innovation
华盛顿州塔科马 98405
活跃,非招募
澳大利亚
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales 2148
活跃,非招募
Orange Health Service (Central West Cancer Care Centre)
Orange, New South Wales 2800
活跃,非招募
Riverina Cancer Care Centre
Wagga Wagga, New South Wales 2650
活跃,非招募
Calvary Mater Newcastle
Waratah, New South Wales 2298
活跃,非招募
Pindara Private Hospital
Benowa, Queensland 4217
活跃,非招募
Icon Cancer Centre South Brisbane
South Brisbane, Queensland 4101
活跃,非招募
Flinders Centre For Innovation in Cancer (Fcic)
Bedford Park, South Australia 5042
活跃,非招募
Lyell McEwin Hospital
Elizabeth Vale, South Australia 5112
活跃,非招募
Monash Health
Clayton, Victoria 3168
活跃,非招募
Austin Health
维多利亚州海德堡 3084
活跃,非招募
The Alfred Hospital
墨尔本,维多利亚州 3004
活跃,非招募
St John of God, Murdoch
Murdoch, Western Australia 6150
活跃,非招募
One Clinical Research
西澳大利亚奈德兰兹 6009
活跃,非招募
中国
The Second Hospital of Anhui Medical University
Hefei, Anhui 230601
活跃,非招募
Peking University First Hospital
Beijing, Beijing 100034
活跃,非招募
Beijing Tsinghua Changgung Hospital
Beijing, Beijing 102218
活跃,非招募
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
活跃,非招募
Quanzhou First Affliated Hospital of Fujian Medical University
Quanzhou, Fujian 362000
活跃,非招募
厦门大学附属第一医院
福建厦门 361003
活跃,非招募
Gansu Provincial Hospital
Lanzhou, Gansu 730000
活跃,非招募
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
Guangzhou, Guangdong 510000
活跃,非招募
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong 510000
活跃,非招募
The First Affiliated Hospital of Shantou University Medical College
广东汕头 515041
活跃,非招募
Nanyang Central Hospital
Nanyang, Henan 473000
活跃,非招募
河南省肿瘤医院
Zhengzhou, Henan 450000
活跃,非招募
Hubei Cancer Hospital
Wuhan, Hubei 430079
活跃,非招募
Hunan Cancer Hospital
湖南长沙 410013
活跃,非招募
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu 213000
活跃,非招募
Nantong First Peoples Hospital
Nantong, Jiangsu 215124
活跃,非招募
Affiliated Hospital of Jiangnan University South Campus
Wuxi, Jiangsu 214122
活跃,非招募
吉林大学第一医院
吉林长春 130021
活跃,非招募
General Hospital of Ningxia Medical University
Yinchuan, Ningxia 750004
活跃,非招募
Shandong Cancer Hospital
Jinan, Shandong 250117
活跃,非招募
Jining No.1 Peoples Hospital West Branch
Jining, Shandong 272000
活跃,非招募
Linyi Peoples Hospital
Linyi, Shandong 276000
活跃,非招募
Qingdao Municipal Hospital
Qingdao, Shandong 266000
活跃,非招募
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai 200000
活跃,非招募
Shanghai 10Th Peoples Hospital
Shanghai, Shanghai 200072
活跃,非招募
Shanghai East Hospital Branch Hospital
Shanghai, Shanghai 200123
活跃,非招募
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi 030013
活跃,非招募
天津医科大学附属肿瘤医院
天津,天津 300060
活跃,非招募
Tianjin Union Medical Center (Nankai University Affiliated Hospital)
Tianjin, Tianjin 300121
活跃,非招募
Karamay Central Hospital of Xinjiang
Karamay, Xinjiang 834009
活跃,非招募
The Xinjiang Uygur Autonomous Region Peoples Hospital
Urumqi, Xinjiang 830001
活跃,非招募
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang 310009
活跃,非招募
波多黎各
Pan American Oncology Trials, Llc
Rio Piedras 00935
活跃,非招募

纳入标准

纳入标准

* Participant must have measurable disease as defined per RECIST version 1.1
* Has a histologically confirmed colorectal adenocarcinoma with metastatic or unresectable disease (Stage IV as defined by American Joint Committee on Cancer [AJCC] 8th edition)
* No prior systemic therapy for colorectal cancer (CRC) in the metastatic setting except for the induction treatment of first-line therapy. Note: Local regional treatment performed during induction systemic treatment is allowed
* Participants who have completed the first-line induction treatment, with an overall response of stable disease or better. The duration of induction treatment should be completed within approximately 6 months. The first dose of study treatment needs to occur within 2 weeks (for 2-week regimen) or 3 weeks (for 3-week regimen) to 6 weeks after Day 1 of the last cycle of induction therapy

排除标准

排除标准:

* Participants whose disease has become resectable at the investigator's discretion during or after induction treatment are not eligible
* Progressive disease occurred less than 6 months from completion of any prior neoadjuvant therapy (ie, chemotherapy with or without radiotherapy) or adjuvant therapy (ie, chemotherapy with or without radiotherapy), whichever occurred later
* Participants who have been treated with anti-epidermal growth factor receptor (EGFR) antibody in the induction treatment
* Any prior therapy targeting T-cell stimulation or checkpoint pathways
* Participants with B-raf proto-oncogene, serine/threonine kinase (BRAF)V600E mutations
* Have locally or centrally confirmed microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR) method or dMMR by immunohistochemistry (IHC) method

Note: Other protocol defined criteria may apply.

NCT ID

NCT05609370

添加审判日期

2022-11-08

更新日期

2025-06-11