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)
Overview
- Phase
- Phase 1
- Intervention
- Toripalimab (JS001 )
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pathological response rate
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Toripalimab (JS001 )
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.
Intervention: Toripalimab (JS001 ) Lenvatinib
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.
Intervention: Toripalimab (JS001 ) Lenvatinib
Outcomes
Primary Outcomes
Pathological response rate
Time Frame: Up to 2 months
CPR，MPR
Secondary Outcomes
- 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)