This study is an open-label, randomized controlled, multicenter, phase III clinical trial
R0 resection of hepatocellular carcinoma (HCC) with a surgical margin <1 cm (determined by postoperative pathology, surgical records, and imaging).
Within 4 months after curative resection.
High-Risk Recurrence Factors (at least one required in addition to narrow margin): (1) Microvascular invasion (MVI) positive, tumor thrombus, or satellite nodules (2) Preoperative AFP >400 ng/mL (3) Tumor >5 cm with incomplete capsule
≥18 and ≤80 years old.
Vp3 or Vp4 portal vein tumor thrombus (PVTT) or Vv2/Vv3 inferior vena cava (IVC) tumor thrombus on preoperative imaging.
Previous anti-HCC therapies, including but not limited to: targeted therapy (e.g., tyrosine kinase inhibitors), immune checkpoint inhibitors (e.g., PD-1/PD-L1 inhibitors) or systemic chemotherapy
Distant metastasis before randomization.
Moderate to severe ascites unresponsive to medical management.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Peking University People's Hospital
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
Beijing 302 Hospital
Collaborator
Beijing Ditan Hospital
Collaborator
Eastern Hepatobiliary Surgery Hospital
Collaborator