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Adjuvant Radiotherapy of Sintilimab Versus TACE for HCC

NCT07186621 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2025-09-22

No results posted yet for this study

Summary

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

Conditions

  • Hepatocellular Carcinoma (HCC)
  • Radiotherapy, Adjuvant
  • Immune Checkpoint Inhibitor
  • TACE
  • Narrow Margin

Interventions

DRUG

Sintilimab

concurrent sintilimab 200mg q3w for 2 cycles followed by maintenance sintilimab 200mg q3w for 15 cycles (approximately 1 year total treatment duration) until disease progression or unacceptable toxicity

RADIATION

radiotherapy

The experimental group will initiate radiotherapy within 4 months postoperatively with prescribed doses of 44-50Gy in 22-25 fractions to the tumor bed and 56-60Gy in 22-25 fractions to narrow-margin areas adjacent to major blood vessels

PROCEDURE

TACE

The control group will receive the first TACE procedure within 4 months postoperatively, with the decision on administering a second TACE to be determined by the investigator based on the patient's condition and first TACE response assessment.

Sponsors & Collaborators

  • Peking University People's Hospital

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    collaborator OTHER

  • Beijing 302 Hospital

    collaborator OTHER

  • Beijing Ditan Hospital

    collaborator OTHER

  • The Third Affiliated Hospital of Naval Medical University

    collaborator UNKNOWN

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Shuhang Wang · NCC, CICAMS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-10
Primary Completion
2027-07-09
Completion
2028-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07186621 on ClinicalTrials.gov