RecruitingPhase 3NCT07186621

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


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

286 participants

Start Date

Jul 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches after surgery for liver cancer (hepatocellular carcinoma, HCC): adding radiotherapy with an immunotherapy drug (sintilimab) versus standard TACE (a procedure that blocks blood supply to the tumor site) in patients at high risk for the cancer coming back. **You may be eligible if...** - You are aged 18–80 and have had liver cancer removed surgically (R0 resection) - Your surgical margin was less than 1 cm and you have at least one high-risk recurrence factor (e.g., microscopic blood vessel invasion, AFP over 400, or tumor larger than 5 cm) - Your surgery was within the past 4 months - Your liver and blood count levels meet the required thresholds **You may NOT be eligible if...** - Your imaging showed remaining cancer in the liver or major blood vessel invasion before surgery - You have previously received targeted therapy, immunotherapy, or other systemic anti-cancer treatment for this liver cancer - You have severe heart function abnormalities Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSintilimab

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

RADIATIONradiotherapy

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

PROCEDURETACE

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.


Locations(1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

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NCT07186621


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