NCT04258111终止2 期
An Open-label, Multicenter, Phase 2 Study of IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR) /microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
The main purpose of this study is to assess the efficacy and safety of IBI310 in combination with sintilimab in patients with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) locally advance or metastatic colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed colorectal adenocarcinoma
- •Imaging confirmed locally-advanced or metastatic colorectal cancer
- •Measurable disease by CT or MRI
- •MSI-H confirmed by central lab
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
排除标准
- •Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- •Subjects with active,known or suspected autoimmune disease
- •Subjects with a history of primary immune deficiency
- •Subjects with severe infectious diseases
研究组 & 干预措施
IBI310 + Sintilimab
Experimental
干预措施: IBI310 (anti-CTLA-4 antibody) (Biological)
IBI310 + Sintilimab
Experimental
干预措施: Sintilimab(anti-PD-1 antibody) (Biological)
结局指标
主要结局
ORR
时间窗: Up to 3 years
Objective Response Rate (ORR) in all MSI-H CRC patients as determined by independent review committee
次要结局
- Progression-Free Survival (PFS) both by investigator and IRC(Up to 3 years)
- Time To Response (TTR) both by investigator and IRC(Up to 3 years)
- ORR in all MSI-H CRC patients based on investigator assessment.(Up to 3 years)
- Disease Control Rate (DCR) both by investigator and IRC(Up to 3 years)
- Duration of Response (DoR) both by investigator and IRC(Up to 3 years)
- Overall Survival(Up to 3 years)
- Incidence of adverse events (AE)(Up to 3 years)
研究者
研究点 (1)
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