A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Camrelizumab (SHR-1210) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 3 期
- 入组人数
- 396
- 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 treatment with Camrelizumab (SHR-1210) + definitive chemoradiotherapy(dCRT) vs placebo+dCRT for locally advanced esophageal cancer patients in China. Camrelizumab (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. Participants receive camrelizumab or placebo + chemotherapy + radiation therapy . The chemotherapy regimens are : paclitaxel plus cisplatin Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) 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
- •1.18 to 75 years; 2.Histologically confirmed diagnosis of localized ESCC; 3.Measurable and/or non-measurable disease defined per RECIST v1.1; 4.ECOG Performance Status ≤ 1; 5.Adequate organ function
排除标准
- •Indicators of severe malnutrition;
- •A history of surgery for esophageal cancer;
- •Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;
- •Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy;
- •Received prior chemotherapy, radiotherapy, targeted therapy or immune-oncology therapies;
- •Active autoimmune diseases or history of autoimmune diseases that may relapse
研究组 & 干预措施
Arm A
Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy.
干预措施: Camrelizumab (Drug)
Arm A
Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy.
干预措施: Paclitaxel (Drug)
Arm A
Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy.
干预措施: Cisplatin (Drug)
Arm A
Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy.
干预措施: Radiation (Radiation)
Arm B
Placebo + Paclitaxel + Cisplatin + Radiotherapy.
干预措施: Paclitaxel (Drug)
Arm B
Placebo + Paclitaxel + Cisplatin + Radiotherapy.
干预措施: Cisplatin (Drug)
Arm B
Placebo + Paclitaxel + Cisplatin + Radiotherapy.
干预措施: Placebo (Drug)
Arm B
Placebo + Paclitaxel + Cisplatin + Radiotherapy.
干预措施: Radiation (Radiation)
结局指标
主要结局
PFS assessed by IRC
时间窗: up to 3 years
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
次要结局
- ORR(up to 3 years)
- PFS assessed by investigators(up to 3 years)
- AE(up to 3 years)
- DoR(up to 3 years)
- OS(up to 3 years)