A Phase 1b/3 Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 453
- 试验地点
- 1
- 主要终点
- Pathological Complete Response(pCR), defined as the proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy.
研究概览
简要总结
Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed the Informed Consent Form (ICF) and complied with the visit and related procedures stipulated by the plan;
- •At least 18 years old.
- •Primary colon adenocarcinoma was histologically confirmed.
- •Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only).
- •MSI-H or dMMR.
- •Radical excision can be performed before neoadjuvant therapy after diagnosis by the investigator.
- •Have at least one evaluable lesion according to the RECIST v1.1 evaluation criteria.
- •The Eastern Cooperative Oncology Group performance status (ECOG PS) is 0 to 1.
排除标准
- •Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
- •Prior treatment with anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) or any other drug acting on T-cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.) and adoptive cellular immunotherapy.
- •Concurrent participation in another clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study.
- •Received any investigational drug or device treatment within 4 weeks prior to initial administration of the investigational drug.
研究组 & 干预措施
Phase Ib Experimental group
In Phase Ib Experimental group，subjects will receive two cycles of neoadjuvant immunotherapy: the first cycle of IBI310 (1mg/kg) & Sintilimab (200mg) and the second cycle of Sintilimab (200mg) only.Followed by radical surgery for colon cancer.
干预措施: IBI310&Sintilimab (Drug)
Phase Ib Control group
In Phase Ib Control group，subjects will receive two cycles of neoadjuvant immunotherapy with 200 mg of sintilimab per cycle, followed by radical surgery for colon cancer.
干预措施: Sintilimab (Drug)
Phase Ib Experimental group
In Phase Ib Experimental group，subjects will receive two cycles of neoadjuvant immunotherapy: the first cycle of IBI310 (1mg/kg) & Sintilimab (200mg) and the second cycle of Sintilimab (200mg) only.Followed by radical surgery for colon cancer.
干预措施: Radical surgery (Procedure)
Phase Ib Control group
In Phase Ib Control group，subjects will receive two cycles of neoadjuvant immunotherapy with 200 mg of sintilimab per cycle, followed by radical surgery for colon cancer.
干预措施: Radical surgery (Procedure)
Phase III Experimental group
In Phase III Experimental group，subjects will receive two cycles of neoadjuvant immunotherapy: the first cycle of IBI310 (1mg/kg) & Sintilimab (200mg) and the second cycle of Sintilimab (200mg) only. Followed by radical surgery for colon cancer. Adjuvant chemotherapy will be given or not according to the pathological stage after surgery.
干预措施: IBI310&Sintilimab (Drug)
Phase III Control group
In Phase III Control group, subjects will receive radical surgery without neoadjuvant therapy. Adjuvant chemotherapy will be given or not according to the pathological stage after surgery.
干预措施: Radical surgery (Procedure)
结局指标
主要结局
Pathological Complete Response(pCR), defined as the proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy.
时间窗: 1 month after surgery
The proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy.
Event Free Survival, EFS(EFS), defined as the time from randomization to the first determination using RECIST v1.1 of inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first.
时间窗: up to 5 years after surgery
The time from randomization to the first determination using RECIST v1.1 of inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first.
次要结局
- Overall-survival(OS), defined as the time from randomization to death from any cause(up to 5 years after surgery)
- R0 tumor resection rate, defined as the proportion of subjects with R0 excision(2 week after surgery)