A Study of the Combination of Anti-PD-1 AK105 and Anlotinib in First-line Hepatocellular Carcinoma (HCC)

Inclusion Criteria: * Signed written informed consent form voluntarily. * Male or female，age over 18 years old (inclusive) and not more than 75 years old (inclusive), when signing the ICF. * Expected life expectance ≥ 3 months. * Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1. * Confirmation either by histology unresectable hepatocellular carcinoma.. * BCLC stage C, and non-resectable BCLC stage B . * No prior systemic therapy for HCC. * Child-Pugh class A and B (≤7 points). * At least one measurable lesion according to RECIST criteria. * Adequate hematologic and end-organ function. * For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent. Exclusion Criteria: * Prior treatment with anti-PD1, anti-PD-L1 or anti-CTLA-4 antibody therapy. * Active ongoing infection requiring therapy. * History of severe hypersensitivity reaction to another monoclonal antibody. * Received any live attenuated vaccine within the last 30 days. * Other malignancy requiring treatment in the prior 5 years with the exception of locally treated squamous or basal cell carcinoma. * Pregnant, breast feeding, or planning to become pregnant. * Active or prior documented autoimmune or inflammatory disease with some exceptions. * Central nervous system metastases and/or carcinomatous meningitis. * Medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication. * Co-infection of HBV and HCV. * Inadequately controlled arterial hypertension.