A Randomized Controlled Multicentered Phase 2/3 Study to Evaluate SHR-1210 (PD-1 Antibody) in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Failed or Intolerable to Prior Systemic Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 17
- 主要终点
- Objective Response Rate
研究概览
简要总结
This a randomized controlled Phase 2/3 study to evaluate the efficacy and safety of SHR-1210 in subjects with advanced HCC who failed or intolerable to prior systemic treatment. The primary study hypothesis is that SHR-1210 treatment improves Objective Response Rate and Overall Survival when compare with SOC.
详细描述
In June 2017, this study was revised to expand the Phase 2 part to enroll more subjects and remove the Phase 3 part under the same protocol. A Phase 3 study will be initiated separately.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed HCC in advanced stage; not suitable to surgery or local regional treatment; with at least one measurable lesion per RECIST 1.1
- •Failed or intolerable to at least one prior systemic treatment for advanced HCC
- •ECOG Performance Status of 0 or1
- •Child-Pugh Class A or B with 7 points
- •Life Expectancy of at least 12 weeks
- •HBV DNA<500 IU/ml
- •Adequate organ function
- •Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 60 days for female subjects and 120 days for male subjects after the last dose of study drug
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- •Known liver transplant or plan to transplant
- •GI hemorrhage with 6 months
- •History or current brain metastases
- •Active known, or suspected autoimmune disease
研究组 & 干预措施
SHR-1210 Q3W
Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks
干预措施: SHR-1210 (Biological)
SHR-1210 Q2W
Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
干预措施: SHR-1210 (Biological)
结局指标
主要结局
Objective Response Rate
时间窗: approximate 3 years
Tumour responses were evaluated by the independent review committee (IRC) according to RECIST 1.1.The primary endpoints were the proportion of patients with a IRC-assessed objective response (defined as the percentage of patients whose best overall response was confirmed complete or partial response).
6-month Overall Survival Rate
时间窗: from the date of the first dose to 6 months
6-month overall survival rate (defined as cumulative overall survival rate from the date of the first dose to 6 months)
次要结局
- Adverse Events(approximate 3 years)
- Overall Survival(approximate 3 years)
- Duration of Response(approximate 3 years)