Evaluate the Safety and Efficacy of Toripalimab Combined With Bevacizumab Versus Sorafenib Therapy for HCC

Conditions

• Advanced Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Toripalimab combined with Bevacizumab — COMBINATION_PRODUCT
  Experimental group: Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). combined with Bevacizumab 15mg/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.
• Sorafenib — DRUG
  Control group: Sorafenib 400mg, po, Bid, continuous administration, until occurrence of termination event specified in the protocol.

Study Details

This is a prospective, randomized, open-label, parallel-group, active controlled, multi-center phase III registration clinical study to observe, compare and evaluate the efficacy and safety of Toripalimab (hereafter referred to as JS001) combined with Bevacizumab versus Sorafenib as the first-line therapy for advanced HCC This study will enroll the patients with locally advanced or metastatic hepatocellular carcinoma who could not be radically cured and not receive any prior systemic therapy. The study will use PFS and OS as the co-primary endpoints, with approximately 280 patients planned to be enrolled.

Key Dates

First listed

Jan 25, 2021

Start date

Oct 15, 2020

Status verified

Aug 2023

Primary completion

Oct 31, 2023

Completion

Dec 31, 2024

Study Design

Enrollment

326 participants (actual)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: Experimental group
  Toripalimab combined with Bevacizumab
• Active Comparator: Control group
  Sorafenib

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to 2 years ]