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)

Phase 2

• Conditions: Advanced Hepatocellular Carcinoma (HCC)
• Interventions: Combination Product: Toripalimab combined with Bevacizumab

• Registration Number: NCT04605796
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-10
• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-28
• Primary Completion: 2020-12-22
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-22
• Last Update Posted: 2021-11-24
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Toripalimab combined with Bevacizumab	Experimental group: Toripalimab combined with Bevacizumab

Primary Outcome Measures

Name	Time	Method
ORR	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]	Up to 2 years	Number and incidence of abnormal laboratory examinations by treatment group.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 2 years	Overall survival is defined as time from the start of treatment until death due to any reason.
TTP	Up to 2 years	time from the start of treatment to progression of diease.
PFS	Up to 2 years	PFS is defined as time from the start of treatment to progression of disease or death.
DoR	Up to 2 years	The time from the first assessment of CR or PR to the first assessment of PD or death due to any cause.
DCR	Up to 2 years	The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.

Trial Locations

Locations (1)

Beijing Cancer hospital; 🇨🇳 Beijing, China