This is a multicenter, randomized, open-label, controlled Phase III clinical study designed to evaluate the efficacy and safety of JS207 in combination with JS007 versus toripalimab in combination with bevacizumab as first-line treatment in participants with advanced HCC.
All study participants have unresectable locally advanced, recurrent, or metastatic HCC and have not previously received systemic anti-tumor therapy for advanced disease.
Approximately 560 participants are planned to be enrolled in this study. The JS207 + JS007 group (experimental group) and the toripalimab + bevacizumab group (positive control group) are each planned to enroll 280 participants.
Voluntarily participate and sign a written informed consent form.
Aged 18-75 years, regardless of sex.
Histologically/cytologically confirmed HCC, or cirrhosis meeting the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for HCC.
No prior systemic therapy for HCC.
Concomitant with the following study disease states: Known intrahepatic cholangiocarcinoma (ICC) or mixed-type liver cancer, sarcomatoid hepatocellular carcinoma, and fibrolamellar carcinoma of the liver; Presence of HCC central nervous system metastasis.
Prior treatment-related toxicity not recovered to ≤ CTCAE Grade 1.
Severe infection at screening.
Uncontrolled pericardial effusion, uncontrolled pleural effusion, or clinically apparent moderate or greater ascites at screening.
Parallel
JS207
DrugPD-1/VEGF bispecific antibody supplied as a lyophilized powder for intravenous infusion.
JS007
DrugCTLA-4 monoclonal antibody supplied as an injectable solution for intravenous infusion.
Toripalimab
DrugPD-1 monoclonal antibody supplied as an injectable solution for intravenous infusion.
Bevacizumab
DrugVEGF monoclonal antibody supplied as an injectable solution for intravenous infusion.
Progression-Free Survival Assessed by Blinded Independent Central Review (BICR-PFS)
Time from randomization to the first documented disease progression assessed by BICR per RECIST v1.1 or death from any cause, whichever occurs first. Tumor assessments use Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Assessments are performed every 6 weeks through Week 54 and every 9 weeks thereafter.
Overall Survival (OS)
Time from randomization to death from any cause. After safety follow-up, survival status is assessed every 2 months until death, loss to follow-up, withdrawal of consent, or study termination.
Progression-Free Survival Assessed by the Investigator (INV-PFS)
Time from randomization to first documented disease progression assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurs first. Tumor assessments use Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Assessments are performed every 6 weeks through Week 54 and every 9 weeks thereafter.
Objective Response Rate Assessed by BICR (ORR)
Percentage of randomized participants whose best overall response is complete response (CR) or partial response (PR). Responses and progression are assessed by blinded independent central review (BICR) per RECIST v1.1.
Objective Response Rate Assessed by the Investigator (ORR)
Percentage of randomized participants whose best overall response is complete response (CR) or partial response (PR). Responses and progression are assessed by the investigator per RECIST v1.1.
Disease Control Rate Assessed by BICR (DCR)
Percentage of randomized participants whose best overall response is complete response (CR), partial response (PR), or stable disease (SD). Responses and progression are assessed by blinded independent central review (BICR) per RECIST v1.1.
Blood Concentrations of JS207
Concentrations of JS207 in serum, measured using the validated bioanalytical assay.
Immunogenicity of JS207 assessed by the presence of antidrug antibodies (ADAs) for JS207
Presence of antidrug antibodies (ADAs) for JS207 (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).
Immunogenicity of JS207 assessed by the presence of antidrug antibodies (NAb) for JS207
Presence of antidrug antibodies (ADAs) for JS207 (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).
Blood Concentrations of JS007
Concentrations of JS007 in serum, measured using the validated bioanalytical assay.
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