Adjuvant Radiotherapy of Sintilimab Versus TACE for HCC

PHASE3RecruitingINTERVENTIONAL
Enrollment

286

Participants

Timeline

Start Date

July 10, 2025

Primary Completion Date

July 9, 2027

Study Completion Date

November 30, 2028

Conditions
Hepatocellular Carcinoma (HCC)Radiotherapy, AdjuvantImmune Checkpoint InhibitorTACENarrow 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.

Trial Locations (1)

Unknown

RECRUITING

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing

All Listed Sponsors
collaborator

Peking University People's Hospital

OTHER

collaborator

Nanfang Hospital, Southern Medical University

OTHER

collaborator

Beijing 302 Hospital

OTHER

collaborator

Beijing Ditan Hospital

OTHER

collaborator

The Third Affiliated Hospital of Naval Medical University

UNKNOWN

lead

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER