Comparison of Immune Checkpint Inhibitors Combined With Chemotherapy Versus Chemotherapy Alone in the Neoadjuvant Treatment of Locally Advanced Colorectal Cancer: a Randomized, Open-label, Single-center Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 3
- 主要终点
- pCR rate
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy and safety of the combination of immune checkpoint inhibitors (ICIs) and FOLFOX regimen compared to FOLFOX regimen alone in the neoadjuvant chemotherapy of locally advanced colorectal cancer. The main question aims to answer are:
Question 1: Compare the pathological complete response rate between the combination of ICIs and FOLFOX regimen and the FOLFOX alone.
Question 2: Compare the survival outcomes and safety between the combination of ICIs and FOLFOX regimen and the FOLFOX alone.
Two groups of participants will receive different new adjuvant chemotherapy regimens, and their efficacy will be compared.
详细描述
A prospective, randomized, open, multi-center clinical study evaluating the efficacy (pathological response, survival outcomes) and safety of the combination of ICIs and FOLFOX regimen compared to FOLFOX regimen in the treatment of locally advanced colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75, no gender restrictions;
- •Histologically or cytologically confirmed colorectal adenocarcinoma;
- •Clinically diagnosed as stage II/III colorectal cancer based on CT and/or MRI (according to the 8th edition of AJCC staging);
- •Sufficient tumor tissue specimens for mismatch repair protein expression or microsatellite instability testing;
- •No prior systemic drug therapy and/or radiotherapy for colorectal adenocarcinoma;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •Normal major organ function, no severe blood, heart, lung, liver, kidney dysfunction, or immune deficiency diseases (see protocol for details);
- •Voluntary participation in this study and signed informed consent form;
- •Expected good compliance to complete the study treatment, follow-up for efficacy and adverse reactions according to the protocol requirements.
排除标准
- •Pathology is other malignant tumors besides adenocarcinoma, such as squamous cell carcinoma, gastrointestinal stromal tumor, melanoma, etc.;
- •Within 5 years prior to the first use of investigational drug, diagnosed with other malignant tumors, excluding effectively treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ cervical cancer and/or breast cancer effectively removed;
- •Any distant metastatic colorectal adenocarcinoma (according to AJCC 8th edition staging, determined as M1), including but not limited to distant lymph node metastasis, liver metastasis, lung metastasis, intraperitoneal dissemination, or malignant peritoneal effusion;
- •Various severe underlying diseases and autoimmune diseases (see protocol for details);
- •Unable to control recurrent bleeding or subjects who received blood transfusion within 2 weeks prior to the first use of investigational drug;
- •Any other circumstances where the investigator believes it may increase the risk associated with participating in the study, the administration of the investigational drug, or affect the subject's ability to receive the investigational drug and the reliability of the study results.
研究组 & 干预措施
ICIs + FOLFOX group
Patients in this group will receive ICIs combined with FOLFOX regimen, specifically: ICIs, intravenous infusion, D1; Oxaliplatin (85mg/m2), intravenous infusion, D1; Calcium folinate (400mg/m2), intravenous infusion, D1; 5-FU (400mg/m2), intravenous infusion, D1, then continuous intravenous infusion of 1200mg/(m2·d)×2d (total amount of 2400mg/m2, infusion for 46-48h) every two weeks. Imaging evaluation will be performed after 3 cycles of preoperative treatment. If the disease is resectable, surgery will be performed. If R0 resection is achieved, the preoperative regimen will continue for up to 9 cycles.
干预措施: Immune checkpoint inhibitor (Drug)
ICIs + FOLFOX group
Patients in this group will receive ICIs combined with FOLFOX regimen, specifically: ICIs, intravenous infusion, D1; Oxaliplatin (85mg/m2), intravenous infusion, D1; Calcium folinate (400mg/m2), intravenous infusion, D1; 5-FU (400mg/m2), intravenous infusion, D1, then continuous intravenous infusion of 1200mg/(m2·d)×2d (total amount of 2400mg/m2, infusion for 46-48h) every two weeks. Imaging evaluation will be performed after 3 cycles of preoperative treatment. If the disease is resectable, surgery will be performed. If R0 resection is achieved, the preoperative regimen will continue for up to 9 cycles.
干预措施: FOLFOX regimen (Drug)
FOLFOX group
Patients in this group will undergo FOLFOX chemotherapy regimen, specifically: Oxaliplatin 85 mg/m2 dissolved in 500 ml of 5% glucose solution, intravenous drip, on Day 1, in combination with calcium folinate (400mg/m2), intravenous infusion, on Day 1, and 5-FU (400mg/m2), intravenous infusion, on Day 1, followed by continuous intravenous infusion of 1200mg/(m2·d) for 2 days (total dose of 2400mg/m2, infusion for 46-48 hours), once every 2 weeks. After 3 cycles of preoperative treatment, imaging evaluation will be performed. If the disease is resectable, surgery will be performed. If R0 resection is achieved, the preoperative treatment regimen will be continued after surgery, for a maximum of 9 cycles.
干预措施: FOLFOX regimen (Drug)
结局指标
主要结局
pCR rate
时间窗: at time of surgery
pathological complete response rate
次要结局
- OS(at 1,2,3 years at follow-up time)
- R0 resection rate(at time of surgical assessment (after 3 cycles), up to 12 months)
- DFS(up to 3 years after intervention)
- 3 years DFS rate(3 years)
研究者
QIAN LIU
Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences