A Phase Ib/II, Open-Label, Multi-Center Study Evaluating the Efficacy and Safety of Neoadjuvant Toripalimab Injection (JS001) or Toripalimab in Combination With Lenvatinib for Patients With Resectable Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pathological response rate
研究概览
简要总结
This study will evaluate efficacy and safety of Toripalimab Injection (JS001) with or without Lenvatinib as a Neoadjuvant Therapy in patients with Resectable Hepatocellular Carcinoma (HCC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- •Patients who previously received anti-programmed death receptor-1 (PD-1) antibody, anti-programmed death ligand-1 (PD-L1) antibody, anti-programmed death ligand-2 (PD-L2) antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies, including those who have participated in a JS001 clinical study;
- •Patients with a history of gastroesophageal varices or active cardia ulcers associated with a high risk of bleeding; Patients who have upper gastrointestinal hemorrhage within 1 year; Patients known to have fibrous layer HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC; Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Group A
During the neoadjuvant period, the patients will receive a single dose JS001 intravenous infusion of 480 mg. After the operation, the patients will receive JS001 240 mg Q3W for up to 48 weeks.
干预措施: Toripalimab (JS001 ) (Drug)
Group B (Toripalimab, Lenvatinib)
During the neoadjuvant period, the patients will receive a single dose JS001 intravenous infusion of 480 mg in combination with oral lenvatinib at a starting dose of 8 or 12 mg once a day. After the operation, the patients will receive JS001 240 mg Q3W and lenvatinib for up to 48 weeks.
干预措施: Toripalimab (JS001 ) Lenvatinib (Drug)
Group C (Toripalimab, Lenvatinib)
During the neoadjuvant period, the patients will receive a single dose JS001 intravenous infusion of 480 mg in combination with oral lenvatinib at a starting dose of 8 or 12 mg once a day. After the operation, the patients will receive JS001 240 mg Q3W for up to 48 weeks.
干预措施: Toripalimab (JS001 ) Lenvatinib (Drug)
结局指标
主要结局
Pathological response rate
时间窗: Up to 2 months
CPR，MPR
次要结局
- Time to operation(up to 8 months)
- Progression free survival(up to 3 years)
- Objective response rate(up to 2 months)
- Overall survival(up to 3 years)
- Incidence of adverse events(up to 3 years)
- Percentage of R0 resection(up to 8 months)