Status:
RECRUITING
Adjuvant Radiotherapy of Sintilimab Versus TACE for HCC
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsors:
Peking University People's Hospital
Nanfang Hospital, Southern Medical University
Conditions:
Hepatocellular Carcinoma (HCC)
Radiotherapy, Adjuvant
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study is an open-label, randomized controlled, multicenter, phase III clinical trial
Detailed Description
This study is an open-label, randomized controlled, multicenter, phase III clinical trial where participants are randomized in a 1:1 ratio to either the experimental or control group. The experimental...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2028
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT07186621
Start Date
July 10 2025
End Date
November 30 2028
Last Update
September 22 2025
Active Locations (1)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China