NCT07071714进行中（未招募）2 期
An Open, Multicenter Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Pathological Complete Response (pCR)
研究概览
简要总结
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-8068 injection in combination with anti-tumor therapies in subjects with 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
- •Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
- •Male or female ≥ 18 years old and ≤75 years old.
- •ECOG performance status of 0-
- •Part A with a life expectancy of ≥2 years. Part B with a life expectancy of ≥12 weeks.
- •Need to provided tumor tissue samples for genetic testing.
排除标准
- •Part B: Accompanied by untreated or active central nervous system (CNS) metastases. Subjects with a history or current history of meningeal metastasis.
- •Part B: Systemic antitumor therapy was received 4 weeks before the start of the study.
- •Part B: Palliative radiotherapy was completed within 14 days before the first dose.
- •Toxicity and/or complications from previous interventions did not return to NCI-CTCAE level ≤1 or exclusion criteria.
- •Subjects with known or suspected interstitial pneumonia.
- •Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion.
- •Have poorly controlled or severe cardiovascular disease.
- •Subjects with active hepatitis B or active hepatitis C.
- •A history of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation.
- •The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention.
- •Any other factors that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate as judged by investigators.
研究组 & 干预措施
Part A Group
Experimental
干预措施: SHR-8068 Injection (Drug)
Part B Group
Experimental
干预措施: SHR-8068 Injection (Drug)
Part A Group
Experimental
干预措施: Adebrelimab Injection (Drug)
Part B Group
Experimental
干预措施: Bevacizumab Injection (Drug)
Part B Group
Experimental
干预措施: Adebrelimab Injection (Drug)
结局指标
主要结局
Pathological Complete Response (pCR)
时间窗: About 7 months.
Progression Free Survival (PFS)
时间窗: About 18 months.
次要结局
- Adverse Events (AEs)(Up to about 18 months.)
- Clinical Complete Response (cCR)(About 60 months.)
- Disease Free Survival (DFS)(About 60 months.)
- Event Free Survival (EFS）(About 60 months.)
- Overall Survival (OS)(About 60 months.)
- Duration of Response (DoR)(About 18 months.)
- Overall Response Rate (ORR)(About 18 months.)
- Disease Control Rate (DCR)(About 18 months.)
研究者
研究点 (1)
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