NCT07186621RecruitingPhase 3
Adjuvant Radiotherapy of Sintilimab Versus TACE for HCC
Adjuvant Radiotherapy Combined With Sintilimab Versus Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma With Narrow Margins and High-Risk Features Following Resection: A Multi-center Phase III Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 22 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is an open-label, randomized controlled, multicenter, phase III clinical trial
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 286 (estimated)
- First submitted
- 16 Sept 2025
- Start date
- 10 Jul 2025
- Primary completion date
- 9 Jul 2027
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07186621
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 286
- From 10 Jul 2025 to the primary completion date, 9 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Previous radiotherapy involving the abdomen.
Other illness
- History of other malignancies, except: carcinoma in situ，early-stage papillary thyroid cancer or basal cell carcinoma of the skin
- Significant cardiac, renal, or other major organ dysfunction.
- Active Autoimmune Disease or Psychiatric Disorders.
- HIV Infection.
Other
- Vp3 or Vp4 portal vein tumor thrombus (PVTT) or Vv2/Vv3 inferior vena cava (IVC) tumor thrombus on preoperative imaging.
- Distant metastasis before randomization.
- Moderate to severe ascites unresponsive to medical management.
- Pregnant or breastfeeding women.
- Currently enrolled in another interventional clinical trial.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.