NCT03859128进行中（未招募）2 期
A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Toripalimab (Recombinant Humanized Anti-PD-1 Monoclonal Antibody, JS001) Versus Placebo as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence Following Radical Resection
Shanghai Junshi Bioscience Co., Ltd.1 个研究点 分布在 1 个国家目标入组 427 人开始时间: 2019年3月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 427
- 试验地点
- 1
- 主要终点
- BICR-RFS
研究概览
简要总结
This study will investigate if Toripalimab (A PD-1 Inhibitor) will improve recurrence-free survival (RFS) compared to placebo in participants with HCC and are at high risk of recurrence after complete resection with no residual of tumour.
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
- •HCC with at least one protocol defined risk factor, diagnosed confirmed by central pathological review and received R0 resection;
- •BICR confirmed no resdual tumor lesions are detected in liver;
- •Child-Puch score, Class A;
- •ECOG score is 0;
排除标准
- •Patients previously received PD-1 antibody, PD-L1 antibody, PD-L2 antibody or CTLA-4 antibodies, including those who have participated in the JS001 clinical study;
- •Portal vein tumor thrombi or liver metastases or recurrent liver cancer;
- •With symptoms of central nervous system metastasis;
- •With any history of active autoimmune disease or autoimmune disease;
- •Known liver diseases with clinical significance;
- •Patients infected by hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D virus (HDV):
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Group B
Placebo Comparator
Placebo 240mg Q3W, up to 16 cycles
干预措施: TORIPALIMAB INJECTION(JS001 ) (Biological)
Group A
Active Comparator
TORIPALIMAB 240mg ,Q3W, up to 16 cycles
干预措施: TORIPALIMAB INJECTION(JS001 ) (Biological)
结局指标
主要结局
BICR-RFS
时间窗: Time frame is up to 100 months (for interim analysis, up to 92 months for Primary analysis)
Defined as the time from randomization to the first documented disease recurrence or death.
次要结局
- Investigator-RFS(up to 100 months)
- 12-month recurrence-free survival rate (RFS12)(up to 100 months)
- 24-month recurrence-free survival rate (RFS24)(up to 100 months)
- Time to recurrence (TTR)(up to 44 months)
- Time to local recurrence (TTLR)(up to 44 months)
- Overall survival (OS)(up to 44 months)
- 12- and 24-month overall survival rate (OS12 and OS24)(up to 44 months)
- Incidence of AEs(up to 44 months)
研究者
研究点 (1)
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