NCT04605796
Unknown
Phase 2
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)
Shanghai Junshi Bioscience Co., Ltd.1 site in 1 country54 target enrollmentApril 10, 2020
ConditionsAdvanced Hepatocellular Carcinoma (HCC)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- ORR
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
ORR
Time Frame: Up to 2 years
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Up to 2 years
Number and incidence of abnormal laboratory examinations by treatment group.
Secondary Outcomes
- Overall survival (OS)(Up to 2 years)
- TTP(Up to 2 years)
- PFS(Up to 2 years)
- DoR(Up to 2 years)
- DCR(Up to 2 years)
Study Sites (1)
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