Adjuvant Radiotherapy of Sintilimab Versus TACE for HCC

Recruiting now · Phase 3

Conditions studied: Hepatocellular Carcinoma (HCC), Radiotherapy, Adjuvant, Immune Checkpoint Inhibitor, TACE, Narrow Margin

In brief

This study is an open-label, randomized controlled, multicenter, phase III clinical trial

Key facts

Study ID

NCT07186621

Run by

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

People needed

286

Starts

2025-07-10

Expected to finish

2028-11-30

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• ECOG score 0-1.
• Child-Pugh Class: A5, A6, or B7.
• Postoperative Contrast-enhanced MRI of the liver must be performed to exclude intrahepatic residual lesions.
• 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.
• 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.
• No significant ECG abnormalities and no severe cardiac dysfunction.
• Serum creatinine (CRE) and BUN ≤2.5× ULN.
• Hb≥80g/L，ANC≥1.0×109 /L，PLT≥40×109 /L.
• Written informed consent obtained.

You may not qualify if…

• 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.
• History of other malignancies, except: carcinoma in situ，early-stage papillary thyroid cancer or basal cell carcinoma of the skin
• Previous radiotherapy involving the abdomen.
• Significant cardiac, renal, or other major organ dysfunction.
• Active Autoimmune Disease or Psychiatric Disorders.
• HIV Infection.
• Pregnant or breastfeeding women.
• Currently enrolled in another interventional clinical trial.

Where it is running

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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