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Withdrawn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
Sponsored by

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
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
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
No
Studies a U.S. FDA-regulated Device Product
No
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
No
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
No
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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