NCT07186621 Adjuvant Radiotherapy of Sintilimab Versus TACE for HCC
| NCT ID | NCT07186621 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Hepatocellular Carcinoma (HCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 286 participants |
| Start Date | 2025-07-10 |
| Primary Completion | 2027-07-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 286 participants in total. It began in 2025-07-10 with a primary completion date of 2027-07-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is an open-label, randomized controlled, multicenter, phase III clinical trial
Eligibility Criteria
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.
Contact & Investigator
Shuhang Wang
STUDY DIRECTOR
NCC, CICAMS
Frequently Asked Questions
Who can join the NCT07186621 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hepatocellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07186621 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 286 participants.
Is NCT07186621 currently recruiting?
Yes, NCT07186621 is actively recruiting participants. Contact the research team at chenboo@outlook.com for enrollment information.
Where is the NCT07186621 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07186621 clinical trial?
NCT07186621 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The principal investigator is Shuhang Wang at NCC, CICAMS. The trial plans to enroll 286 participants.
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