Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT07186621

Adjuvant Radiotherapy of Sintilimab Versus TACE for HCC

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-09-22

286

Participants Needed

1

Research Sites

177 weeks

Total Duration

On this page

Sponsors

C

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead Sponsor

P

Peking University People's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Adjuvant Radiotherapy of Sintilimab Versus TACE for HCC

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • R0 resection of hepatocellular carcinoma (HCC) with a surgical margin <1 cm confirmed by pathology, surgical records, and imaging
  • Surgery performed within 4 months prior to enrollment
  • Presence of at least one high-risk recurrence factor: microvascular invasion (MVI) positive, tumor thrombus, satellite nodules, preoperative AFP >400 ng/mL, or tumor >5 cm with incomplete capsule
  • Age between 18 and 80 years
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Child-Pugh liver function class A5, A6, or B7
  • Postoperative contrast-enhanced MRI of the liver showing no residual intrahepatic lesions
  • If positive for HBV DNA or HCV RNA, ALT must be less than 1.5 times the upper limit of normal and antiviral therapy must be started
  • Liver function tests with ALT ≤2.5 times ULN (if HBV/HCV positive, ALT ≤1.5 times ULN), AST ≤6 times ULN if ALT ≤1.5 times ULN, or AST ≤2.5 times ULN if ALT is 1.5-2.5 times ULN
  • No significant ECG abnormalities or severe cardiac dysfunction
  • Serum creatinine and blood urea nitrogen (BUN) levels ≤2.5 times ULN
  • Hemoglobin ≥80 g/L, absolute neutrophil count ≥1.0×10⁹/L, and platelet count ≥40×10⁹/L
  • Written informed consent obtained
Not Eligible

You will not qualify if you...

  • Presence of advanced portal vein or inferior vena cava tumor thrombus (Vp3, Vp4, Vv2, or Vv3) on preoperative imaging
  • Prior treatments for hepatocellular carcinoma including targeted therapy, immune checkpoint inhibitors, or systemic chemotherapy
  • Evidence of distant metastasis before randomization
  • Moderate to severe ascites not responding to treatment
  • History of other cancers except carcinoma in situ, early-stage papillary thyroid cancer, or basal cell skin carcinoma
  • Previous abdominal radiotherapy
  • Severe dysfunction of heart, kidneys, or other major organs
  • Active autoimmune diseases or psychiatric disorders
  • HIV infection
  • Pregnant or breastfeeding women
  • Participation in another interventional clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Actively Recruiting

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Research Team

B

Bo Chen, MD.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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