PD-1 Antibody SHR-1210 Combined With Paclitaxel and Cisplatin Versus Placebo Combined With Paclitaxel and Cisplatin as First-line Therapy for Advanced Esophageal Cancer: a Randomized, Double-blinded, Controlled, Multi-center Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 596
- 试验地点
- 1
- 主要终点
- PFS assessed by IRC
研究概览
简要总结
This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of SHR-1210 + paclitaxel + cisplatin vs placebo+paclitaxel +cisplatin as 1L therapy for advanced esophageal cancer patients in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
详细描述
In this study, eligible subjects will be randomized into study arm or control arm. Treatment cycles of chemotherapy will be at most 6 cycles which would be decided by the investigators. Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) and overall survival (OS) will be the primary outcomes.
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
- •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;
- •Tissue samples should be provided for biomarkers (such as PD-L1) analysis;
- •Adequate organ and bone marrow function;
排除标准
- •Allergic to monoclonal antibodies, any SHR-1210 components, paclitaxel, cisplatin and other platinum drugs;
- •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
SHR-1210 + paclitaxel + cisplatin
Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，SHR-1210 200mg，Day 2，every 3 weeks, maximum 6 cycles, then SHR-1210 maintenance
干预措施: SHR-1210 (Drug)
SHR-1210 + paclitaxel + cisplatin
Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，SHR-1210 200mg，Day 2，every 3 weeks, maximum 6 cycles, then SHR-1210 maintenance
干预措施: paclitaxel (Drug)
SHR-1210 + paclitaxel + cisplatin
Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，SHR-1210 200mg，Day 2，every 3 weeks, maximum 6 cycles, then SHR-1210 maintenance
干预措施: cisplatin (Drug)
placebo+paclitaxel + cisplatin
Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，placebo，Day 2，every 3 weeks, maximum 6 cycles, then placebo maintenance
干预措施: Placebo (Drug)
placebo+paclitaxel + cisplatin
Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，placebo，Day 2，every 3 weeks, maximum 6 cycles, then placebo maintenance
干预措施: paclitaxel (Drug)
placebo+paclitaxel + cisplatin
Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，placebo，Day 2，every 3 weeks, maximum 6 cycles, then placebo maintenance
干预措施: cisplatin (Drug)
结局指标
主要结局
PFS assessed by IRC
时间窗: approximately 22 months
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
OS
时间窗: approximately 22 months
OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier.
次要结局
- PFS assessed by investigators(approximately 22 months)
- 6 and 9 month OS rate(approximately 6 and 9 months)
- ORR(approximately 22 months)
- DCR(approximately 22 months)
- DoR(approximately 22 months)
- AE(approximately 22 months)