NCT03099382已完成3 期
A Randomized, Open-Label, Active-Controlled, Multi-Center, Phase III Clinical Study of Anti-PD-1 Antibody SHR-1210 vs. Investigator's Choice of Chemotherapy in Subjects With Locally Advanced or Metastatic Esophageal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 457
- 试验地点
- 2
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
In this study, participants with advanced or metastatic squamous cell carcinoma of the esophagus that has progressed after first-line standard therapy will be randomized to receive either single agent SHR-1210 or the Investigator's choice of standard therapy with docetaxel or irinotecan. The primary study hypothesis is that treatment with SHR-1210 will prolong overall survival (OS) as compared to treatment with standard therapy.
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
- •age: 18-75 years, male or female.
- •Histologically or cytologically confirmed Squamous Cell Carcinoma of the Esophagus, locally advanced, unresectable disease, recurrent or Metastatic disease.
- •Fail to the first-line standard therapy.
- •Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.
- •Can provide either a newly obtained or archival tumor tissue sample.
- •Life expectancy of greater than 12 weeks.
- •Adequate organ function.
- •Female: child bearing potential, a negative urine or serum pregnancy test result within 72 h before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 3 months after the last dose of SHR-1210 or through 180 days after the last dose of docetaxel or irinotecan.
- •Patient has given written informed consent.
排除标准
- •Has a known additional malignancy within the last 5 years before study treatment with the exception of curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers.
- •Known central nervous system (CNS) metastases.
- •Subjects with any active autoimmune disease or history of autoimmune disease.
- •Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
- •Active infection or an unexplained fever > 38.5°C before two weeks of randomization (subjects with tumor fever may be enrolled at the discretion of the investigator);
- •History of Interstitial Pneumonia or received Corticosteroids for non-infectious pneumonitis.
- •Known Human Immunodeficiency Virus (HIV) infection, active Hepatitis B or Hepatitis C.
- •BMI, <18.5mg/m2 or ≥10% weight lost before screening.
- •Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent.
- •Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR-1210 formulation, allergy, hypersensitivity, or contraindication to docetaxel, or irinotecan.
- •Concurrent medical condition requiring the use of cortisol ( >10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. Except: inhalation or topical corticosteroids. Doses > 10 mg/day prednisone or equivalent for replacement therapy.
- •Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent.
- •Currently participating or has participated in a study within 4 weeks of the first dose of study medication.
- •Received a live vaccine within 4 weeks of the first dose of study medication.
- •Pregnancy or breast feeding.
- •According to the investigator, other conditions that may lead to stop the research.
研究组 & 干预措施
camrelizumab
Experimental
干预措施: camrelizumab (Biological)
Investigator's Choice of Standard Therapy
Active Comparator
Docetaxel or Irinotecan
干预措施: Docetaxel (Drug)
Investigator's Choice of Standard Therapy
Active Comparator
Docetaxel or Irinotecan
干预措施: Irinotecan (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: approximately 24 months
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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