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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

Primary Purpose

Hepatocellular Carcinoma (HCC)

Status

Withdrawn

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

HLX10

HLX04

Sorafenib

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma (HCC) focused on measuring Locally Advanced or Metastatic, Hepatocellular Carcinoma (HCC)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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;

Sites / Locations

Ethics committee of zhongshan hospital affiliated to fudan university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

A (treatment group)

B (control group)

Arm Description

HLX10 in combination with HLX04

sorafenib

Outcomes

Primary Outcome Measures

tumor assessment

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

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT04465734

First Posted

July 7, 2020

Last Updated

May 1, 2022

Sponsor

Shanghai Henlius Biotech

1. Study Identification

Unique Protocol Identification Number

NCT04465734

Brief Title

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

Official Title

A Randomized, Open-Label, Controlled, Multicenter, Phase III Clinical Study to Compare the Efficacy and Safety of HLX10 (Anti-PD-1 Antibody) in Combination With HLX04 (Anti-VEGF Antibody) Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Withdrawn

Why Stopped

The trial used sorafenib as a control drug. It's not suitable now(after the A+T has been approved).The sponsor terminated the trial.

Study Start Date

November 15, 2022 (Anticipated)

Primary Completion Date

October 15, 2023 (Anticipated)

Study Completion Date

March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Henlius Biotech

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma (HCC)

Keywords

Locally Advanced or Metastatic, Hepatocellular Carcinoma (HCC)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A (treatment group)

Arm Type

Experimental

Arm Description

HLX10 in combination with HLX04

Arm Title

B (control group)

Arm Type

Sham Comparator

Arm Description

sorafenib

Intervention Type

Drug

Intervention Name(s)

HLX10

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

HLX04

Other Intervention Name(s)

HLX04 ( anti-VEGF antibody )

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sorafenib

Intervention Description

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

Primary Outcome Measure Information:

Title

tumor assessment

Description

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

Time Frame

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

Title

tumor assessment

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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;

Facility Information:

Facility Name

Ethics committee of zhongshan hospital affiliated to fudan university

City

Shanghai

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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