JS207 Plus JS007 Versus Toripalimab Plus Bevacizumab as First-Line Treatment for Advanced Liver Cancer

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.

Inclusion Criteria: * 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. * At least one measurable lesion per RECIST v1.1 criteria. * Child-Pugh liver function grade A or grade B with a score ≤7, and no history of hepatic encephalopathy. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1. * Expected survival ≥ 12 weeks. * Adequate hematologic and end-organ function. * Female participants of childbearing potential and male participants with female partners of childbearing potential must use a highly effective contraceptive method during the study and for at least 6 months after the last dose. Female participants of childbearing potential must have a negative blood HCG test within 7 days prior to study enrollment and must not be breastfeeding. Exclusion Criteria: * 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. -≥ Grade 3 (NCI-CTCAE v6.0) gastrointestinal or non-gastrointestinal fistula at screening. * Severe unhealed wounds, active ulcers, or untreated fractures at screening. * Severe cardiovascular or cerebrovascular disease: * History of gastrointestinal bleeding within 6 months prior to the first dose, or definite tendency for gastrointestinal bleeding. * Other obvious bleeding tendency or evidence of major coagulation disorders: * Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose. * Malignancy other than HCC within 5 years prior to the first dose. * Confirmed or suspected moderate-to-severe pulmonary disease severely affecting pulmonary function. * Active tuberculosis. * Co-infection with hepatitis B and hepatitis C. * Known history of human immunodeficiency virus (HIV) infection, prior allogeneic stem cell or solid organ transplantation, or other immunodeficiency. * Known history of severe allergy to any monoclonal antibody. * Other factors that, in the investigator's judgment, may affect study results or lead to forced premature termination of the study.