MedTrace Logo

A Clinical Study to Compare the Efficacy and Safety of HLX10 in Combination With HLX04 Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic HCC

NCT04465734 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-05-05

No results posted yet for this study

Summary

This study is a randomized, double-blind, multicenter, phase III clinical study to compare the efficacy and safety of HLX10 + HLX04 vs Sorafenibas as the First-line Treatment in Patients with Locally Advanced or Metastatic HCC

Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows:

Arm A (treatment group): HLX10 + HLX04 Arm B (control group): sorafenib Randomization is stratified by: region (Asia (excluding Japan) vs. others), HBV infection vs. HCV infection vs. no HBV or HCV infection, portal vein invasion or/and extrahepatic spread (with vs.without), and ECOG (0 vs. 1).

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

DRUG

HLX10

HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.

DRUG

HLX04

HLX04 is an recombinant anti-VEGF humanized monoclonal antibody ，developed by Shanghai Henlius Biotech, Inc.

DRUG

Sorafenib

Sorafenib is a multi-target, multi-kinase inhibitor capable.The standard treatment of HCC.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2023-10-15
Completion
2024-03-15

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04465734 on ClinicalTrials.gov