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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
HLX10 is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc.
HLX04 is an recombinant anti-VEGF humanized monoclonal antibody ,developed by Shanghai Henlius Biotech, Inc.
Sorafenib is a multi-target, multi-kinase inhibitor capable.The standard treatment of HCC.
Ethics committee of zhongshan hospital affiliated to fudan university
Shanghai, China
tumor assessment
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)
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)
Time frame: Baseline until disease progression or death, whichever occurs first (up to approximately 12 months)
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