A Single-arm, Open-label, Multi-center Phase II Clinical Study to Evaluate the Safety and Efficacy of Toripalimab Injection (JS001) Combined With Bevacizumab as the First-line Therapy for Advanced Hepatocellular Carcinoma (HCC)
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Study ID
- NCT04605796
- Phase
- PHASE2
- Status
- Completed
Conditions
- Advanced Hepatocellular Carcinoma (HCC)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Toripalimab combined with Bevacizumab — COMBINATION_PRODUCTExperimental group: Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). combined with Lenvatinib 15 mg/kg (IV infusion, every 3 weeks (q3w).. Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol.
Study Details
This is an open-label, single-arm, national multicenter phase II clinical study to preliminarily observe and evaluate the efficacy and safety of Toripalimab combined with Bevacizumab as the first-line therapy for advanced HCC The study will use safety/tolerability and ORR as the primary study objectives and indicators, and plans to enroll about 50-60 patients.
Key Dates
- First listed
- Oct 28, 2020
- Start date
- Apr 10, 2020
- Status verified
- Jul 2026
- Primary completion
- Oct 27, 2022
- Completion
- May 30, 2023
Study Design
- Enrollment
- 54 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Single ArmExperimental group: Toripalimab combined with Bevacizumab
Primary Outcome Measure
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 2 years ]