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.
Single group
AK112
DrugAfter enrollment, patients receive AK112 at 20 mg/kg, administered via intravenous infusion on day 1 of each cycle, every 3 weeks (Q3W). After four cycles, surgery is performed four weeks after the last dose. AK112 at 20 mg/kg is administered again four to eight weeks after surgery, via intravenous infusion on day 1 of each cycle, every 3 weeks (Q3W), until disease progression, death, intolerable toxicity, withdrawal of consent, initiation of new anti-tumor therapy, or other reasons specified in the protocol for discontinuation of treatment. The maximum postoperative treatment duration with AK112 is 12 months.
Progression-free survival (PFS)
Progression-free survival is defined as the time from the start of treatment with AK112 until the first documentation of disease progression or death due to any cause, whichever occurs first.
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