A Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy as First-line Treatment in Previously Untreated Patients With Unresectable or Metastatic Hepatocellular Carcinoma
This study is a randomized, controlled, open-label, multicenter, seamless Phase II/III trial designed to evaluate the efficacy and safety of the combination regimen of IBI310 and sintilimab in participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who are: (1) treatment-naive to systemic therapy; and (2) either unsuitable for curative-intent surgical resection or local therapy, or have experienced disease progression following prior surgical resection or local therapy.
• Histologically or cytologically confirmed hepatocellular carcinoma (HCC).
• Age ≥18 years and ≤75 years.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
• Barcelona Clinic Liver Cancer (BCLC) staging of Stage C, or Stage B that is unsuitable for curative-intent surgery and/or locoregional therapy.
• No prior systemic antineoplastic therapy for HCC before first dose.
• At screening, per RECIST 1.1, there must be at least one measurable lesion that has not undergone local therapy, or a measurable lesion that has clearly progressed following local therapy (per RECIST 1.1).
• Child-Pugh score ≤7.
• Adequate organ and bone marrow function.
• Expected survival ≥12 weeks at the time of treatment initiation.
⁃ Female participants of childbearing potential, or male participants whose sexual partners are of childbearing potential, must use effective contraception throughout the treatment period and for 15 months after the last dose of oxaliplatin (for females) / 12 months after the last dose of oxaliplatin (for males), or for 6 months after the last dose of any other investigational drug-whichever period ends later.
⁃ Signed written informed consent form, and ability to comply with scheduled visits and all protocol-specified procedures.