Adjuvant Radiotherapy of Sintilimab Versus TACE for HCC

Inclusion Criteria

• •1. R0 resection of hepatocellular carcinoma (HCC) with a surgical margin \<1 cm (determined by postoperative pathology, surgical records, and imaging).
• •2. Within 4 months after curative resection.
• •3. 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
• •4. ≥18 and ≤80 years old.
• •5. ECOG score 0-1.
• •6. Child-Pugh Class: A5, A6, or B7.
• •7. Postoperative Contrast-enhanced MRI of the liver must be performed to exclude intrahepatic residual lesions.
• •8. HBV DNA and HCV RNA status do not affect eligibility, but if HBV DNA positive and/or HCV RNA positive: ALT must be \<1.5× upper limit of normal (ULN). Antiviral therapy must be initiated.
• •9. Liver Function Tests (LFTs): ALT ≤2.5× ULN (if HBV/HCV positive, ALT ≤1.5× ULN). If ALT ≤1.5× ULN, AST ≤6× ULN (excluding AST elevation due to myocardial infarction). If ALT 1.5-2.5× ULN, AST ≤2.5× ULN.
• •10. No significant ECG abnormalities and no severe cardiac dysfunction.
• •11. Serum creatinine (CRE) and BUN ≤2.5× ULN.
• •12. Hb≥80g/L，ANC≥1.0×109 /L，PLT≥40×109 /L.
• •13. Written informed consent obtained.