This study is a single-arm, open-label study. To assess the efficacy and safety of AK112 therapy in patients with resectable hepatocellular carcinoma at high risk of recurrence. The primary endpoint is the 12-month RFS rate of resectable hepatocellular carcinoma.
Single lesion more than 5 cm in longest diameter.
Microvascular or macrovascular invasion.
More than 3 tumor nodules.
Edmondson grade at least II on tumor pathology.
Past histological/cytological diagnosis of fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, cholangiocarcinoma, etc.
Other malignancies within 5 years before enrollment, except those locally treated HCC. Exceptions include basal/squamous cell skin cancer, superficial bladder cancer, cervical/ breast carcinoma in situ.
History of hepatic encephalopathy or liver transplantation.
Cancer thrombus in portal vein branches, superior mesenteric vein, or inferior vena cava.