A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection

Inclusion Criteria: 1. Pathological diagnosis of HCC without any metastasis; 2. Receiving radical resection as the only anti-tumor treatment; 3. No evidence of residual cancer found during or after the operation; 4. Presence of any high risk factor of postoperative recurrence; 5. Child-Pugh grade: A; 6. ECOG score: 0; 7. Controlled underlying causes of HCC. Exclusion Criteria: 1. Fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc; 2. Any anti-tumor treatment other than radical surgery before randomization; 3. Precarious liver function indicated by severe complications; 4. Recent procedures or medications leading to high risk of bleeding; 5. Poorly controlled or symptomatic hypertension, congestive heart failure, arrhythmia, etc; 6. Failure of performing enhanced CT or MRI scans of the liver; 7. Recent severe infections or systemic antibiotics use; 8. Active autoimmune diseases; 9. History of other incurable malignant tumors; 10. History of transplantation; 11. Pregnancy.