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

NCT ID: NCT04465734

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2024-03-15

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A (treatment group)

HLX10 in combination with HLX04

Group Type: EXPERIMENTAL

HLX10

Intervention Type: DRUG

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

HLX04

Intervention Type: DRUG

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

B (control group)

sorafenib

Group Type: SHAM_COMPARATOR

Sorafenib

Intervention Type: DRUG

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

Interventions

HLX10

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

Intervention Type: DRUG

HLX04

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

Intervention Type: DRUG

Sorafenib

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

Intervention Type: DRUG

Other Intervention Names

HLX04 ( anti-VEGF antibody )

Eligibility Criteria

Inclusion Criteria

1. Volunteer to participate in the clinical study;

2. Aged ≥ 18 years and ≤ 75 years;

3. Patients with histopathologically or cytologically diagnosed locally advanced or metastatic and/or unresectable HCC , or patients with clinically diagnosed HCC according to the diagnostic criteria of the American Association for the Study of Liver Diseases (AASLD);

4. Barcelona Clinic Liver Cancer (BCLC) Stage C; or BCLC Stage B patients who are not candidates for radical surgery and/or locoregional therapy.

5. Received no prior systemic HCC treatment (including chemotherapy, treatment with sorafenib, regorafenib, lenvatinib, or other small-molecule antiangiogenic agents);

6. At least one measurable lesion by the IRRC (central radiography) as per RECIST v1.1

7. Normal major organ functions as defined

Exclusion Criteria

1. Patients with known hepatobiliary cell carcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma;

2. History of hepatic encephalopathy;

3. Patients with portal hypertension complicated with upper gastrointestinal hemorrhage, or esophageal/gastric fundal varices with the red color sign, or high hemorrhage risk investigated by the investigator within 6 months before the randomization. Subjects must receive endoscopic examinations to rule out high hemorrhage risk (e.g. red color sign and severe varices) before enrollment.

4. Patients with portal vein invasion at the main portal branch (Vp4), inferior vena cava involvement, or right cardiac involvement of HCC based on imaging examination. Patients with portal vein invasion at the main portal branch but with unobstructed blood flow in the bilateral or unilateral branch can be enrolled;

5. Central nervous system (CNS) or leptomeningeal metastases;

6. Positive for both HBV-DNA and HCV-RNA;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ethics committee of zhongshan hospital affiliated to fudan university

Shanghai, , China

Countries

China

Other Identifiers

HLX10-009-HCC301

Identifier Type: -

Identifier Source: org_study_id