Post-surgery radiotherapy plus sintilimab versus TACE for liver cancer with narrow surgical margins

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, randomized phase III trial randomizing patients 1:1 to either adjuvant radiotherapy with concurrent and maintenance sintilimab or to postoperative TACE. The radiotherapy arm delivers 44–50 Gy to the tumor bed and 56–60 Gy to narrow‑margin areas in 22–25 fractions, with sintilimab 200 mg every 3 weeks for 2 concurrent cycles followed by up to 15 maintenance cycles. The TACE arm receives the first embolization within 4 months after surgery, with additional TACE per investigator judgment. The primary endpoint is 2‑year recurrence‑free survival, and secondary endpoints include 2‑year overall survival and treatment safety.

Why it matters

Who can join: the full rules

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.

Exclusion Criteria:

1. Vp3 or Vp4 portal vein tumor thrombus (PVTT) or Vv2/Vv3 inferior vena cava (IVC) tumor thrombus on preoperative imaging.
2. 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
3. Distant metastasis before randomization.
4. Moderate to severe ascites unresponsive to medical management.
5. History of other malignancies, except: carcinoma in situ，early-stage papillary thyroid cancer or basal cell carcinoma of the skin
6. Previous radiotherapy involving the abdomen.
7. Significant cardiac, renal, or other major organ dysfunction.
8. Active Autoimmune Disease or Psychiatric Disorders.
9. HIV Infection.
10. Pregnant or breastfeeding women.
11. Currently enrolled in another interventional clinical trial.

Where it's running

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  Beijing, China Recruiting

Study contacts

• Study coordinator: Bo Chen, MD.
• Email: chenboo@outlook.com
• Phone: 8610-87788245

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.