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Phase III Trial of Adjuvant Radiotherapy in Combination with Sintilimab versus Adjuvant TACE for Hepatocellular Carcinoma with Postoperative Narrow Margin

Research on Perioperative Precision Treatment Strategies for Resectable Liver Cancer (A Multicenter Phase III Randomized Controlled Study Comparing Adjuvant Radiotherapy Combined with Sindilizumab Versus Adjuvant TACE for Hepatocellular Carcinoma with Narrow Surgical Margins and High-Risk Factors)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115642
Enrollment
Unknown
Registered
2025-12-29
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Interventions

treatment group:Radiotherapy plus Sintilimab
Control group:Interventional therapy

Sponsors

Cancer Hospital Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.R0 resection of hepatocellular carcinoma (HCC) with a surgical margin 400 ng/mL (3) Tumor >5 cm with incomplete capsule; 4.>=18 and =80g/L,ANC>=1.0×10^9 /L,PLT>=40×10^9 /L. 13.Written informed consent obtained.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
2-year recurrent free survival;

Secondary

MeasureTime frame
Adverse events;2-year overall survival;

Countries

China

Contacts

Public ContactBo Chen

Cancer Hospital Chinese Academy of Medical Sciences

cbchinese@163.com+86 10 8778 8280

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026