NCT03732508Unknown2 期
SHR-1316, a Novel Anti-PD-L1 Antibody, in Combination With Irinotecan Liposome and Fluorouracil in Patients With Esophageal Squamous Cell Cancer: a Phase II Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Duration of Progression-Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate the progression-free survival (PFS) of Chemotherapy combined with SHR-1316 in patients with advanced esophageal squamous cell 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma;
- •No previous systemic anti-tumor treatment;
- •Subjects must have at least one measurable tumor lesion per RECIST 1.1;
- •Adequate organ and bone marrow function;
排除标准
- •Allergic to monoclonal antibodies, any SHR-1316 components,Irinotecan , Fluorouracil ;
- •Prior therapy as follow:
- •Anti-PD-1 or anti-PD-L1;
- •Any experimental drugs within 4 weeks of the first dose of study medication;
- •Received major operations or serious injuries within 4 weeks of the first dose of study medication;
- •Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication;
- •Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;
- •Subjects with any active autoimmune disease or history of autoimmune disease;
- •Pregnancy or breast feeding;
研究组 & 干预措施
Irinotecan liposome plus SHR1316 plus fluorouracil
Experimental
干预措施: Irinotecan liposome (Drug)
Irinotecan liposome plus SHR1316 plus fluorouracil
Experimental
干预措施: SHR-1316 (Drug)
Irinotecan liposome plus SHR1316 plus fluorouracil
Experimental
干预措施: Fluorouracil (Drug)
结局指标
主要结局
Duration of Progression-Free Survival (PFS)
时间窗: approximately 22 months
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
次要结局
- Disease Control Rate(DCR)(approximately 22 months)
- Objective Response Rate(ORR)(approximately 22 months)
- Overall Survival(OS)(approximately 22 months)
- Adverse Events(AE)(approximately 22 months)
研究者
研究点 (1)
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