A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of CS1001 in Combination With Fluorouracil and Cisplatin (FP) Compared to Placebo in Combination With FP as First-Line Therapy in Subjects With Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 540
- 试验地点
- 72
- 主要终点
- Overall survival (OS)
研究概览
简要总结
Phase III Study to Investigate the Efficacy and Safety of CS1001 or Placebo in Combination with FP as First-Line Therapy in Subjects with Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CS1001+ Fluorouracil+Cisplatin
干预措施: CS1001+ Fluorouracil+Cisplatin (Drug)
Placebo+ Fluorouracil+Cisplatin
干预措施: Placebo+ Fluorouracil+Cisplatin (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Approximately 43 months from the time of randomization
OS was defined as the time from randomization to death due to any cause.
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
时间窗: Approximately 43 months from the time of randomization
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by BICR, or death due to any cause, whichever occurred first.
次要结局
- Duration of response (DoR) assessed by BICR and investigators according to RECIST v1.1(Approximately 43 months from the time of randomization)
- PFS assessed by investigators according to RECIST v1.1(Approximately 43 months from the time of randomization)
- Objective response rate (ORR) assessed by BICR and investigators according to RECIST v1.1(Approximately 43 months from the time of randomization)