A Single-arm, Open-label, Multi-center Phase II Clinical Study to Evaluate the Safety and Efficacy of Toripalimab Injection (JS001) Combined With Bevacizumab as the First-line Therapy for Advanced Hepatocellular Carcinoma (HCC)

Inclusion Criteria

• •1. Age of 18-70 years (inclusive), male or female.
• •2. HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2017 Edition).
• •3. Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage). In case of stage B, the patient must be unsuitable for surgery and/or local therapy, or have progressive disease after surgery and/or local therapy, or refuse surgery and/or local therapy (special instruction and signature required).
• •4. No previous use of any systemic therapy or HCC.
• •5. Having ≥ 1 measurable lesion in accordance with RECISTv1.1.
• •6. Grade A Child-Pugh hepatic function, with no history of hepatic encephalopathy.
• •7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-1.
• •8. Expected survival ≥12 weeks.
• •9. Adequate hematologic and end-organ function..
• •10. In case of HBsAg (+) and/or HBcAb (+), HBV DNA is required to be \< 500 IU/mL, and it is required to continue the effective anti-HBV therapy that has been adopted in the full course, or start to use Entecavir or tenofovir in the full course during the study. HBV/HCV co-infected patients will be excluded. Patients with a history of HCV infection but with negative HCV RNA PCR results can be considered uninfected with HCV.
• +23 more criteria