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NCT04465734 | Withdrawn Phase 3 DMC

• 1 other identifier: HLX10-009-HCC301
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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)

Keywords

Locally Advanced or Metastatic; Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (2)

• tumor assessment

  Overall survival (OS): defined as a period from randomization to death of the subject for any reason.

  defined as a period from randomization to death of the subject for any reason (up to approximately 24 months)

• tumor assessment

  Progression-free survival (PFS) (assessed by the independent radiology review committee \[IRRC\] based on Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)

  Baseline until disease progression or death, whichever occurs first (up to approximately 12 months)

Study Arms (2)

A (treatment group)

EXPERIMENTAL

HLX10 in combination with HLX04

Drug: HLX10; Drug: HLX04

B (control group)

SHAM COMPARATOR

sorafenib

Drug: Sorafenib

Interventions

HLX10 DRUG

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

A (treatment group)

HLX04 DRUG

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

Also known as: HLX04 ( anti-VEGF antibody )

A (treatment group)

Sorafenib DRUG

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

B (control group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer to participate in the clinical study;
• Aged ≥ 18 years and ≤ 75 years;
• 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);
• Barcelona Clinic Liver Cancer (BCLC) Stage C; or BCLC Stage B patients who are not candidates for radical surgery and/or locoregional therapy.
• Received no prior systemic HCC treatment (including chemotherapy, treatment with sorafenib, regorafenib, lenvatinib, or other small-molecule antiangiogenic agents);
• At least one measurable lesion by the IRRC (central radiography) as per RECIST v1.1
• Normal major organ functions as defined

You may not qualify if:

• Patients with known hepatobiliary cell carcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma;
• History of hepatic encephalopathy;
• 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.
• 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;
• Central nervous system (CNS) or leptomeningeal metastases;
• Positive for both HBV-DNA and HCV-RNA;

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

Ethics committee of zhongshan hospital affiliated to fudan university

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasm Metastasis

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: November 15, 2022
• Primary Completion: October 15, 2023
• Study Completion: March 15, 2024
• Last Updated: May 5, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)