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

Inclusion criteria

• Pathological diagnosis of HCC without any metastasis;
• Receiving radical resection as the only anti-tumor treatment;
• No evidence of residual cancer found during or after the operation;
• Presence of any high risk factor of postoperative recurrence;
• Child-Pugh grade: A;
• ECOG score: 0;
• Controlled underlying causes of HCC.

Exclusion criteria

• Fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc;
• Any anti-tumor treatment other than radical surgery before randomization;
• Precarious liver function indicated by severe complications;
• Recent procedures or medications leading to high risk of bleeding;
• Poorly controlled or symptomatic hypertension, congestive heart failure, arrhythmia, etc;
• Failure of performing enhanced CT or MRI scans of the liver;
• Recent severe infections or systemic antibiotics use;
• Active autoimmune diseases;
• History of other incurable malignant tumors;
• History of transplantation;
• Pregnancy.