HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence

PHASE2RecruitingINTERVENTIONAL
Enrollment

165

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

January 31, 2028

Conditions
Hepato Cellular Carcinoma (HCC)
Interventions
DRUG

HAIC combined with sintilimab and donafenib

"HAIC: Two cycles, Q3W. The chemotherapy regimen consists of oxaliplatin 85 mg/m² over 2 hours and raltitrexed 2 mg/m² over 1 hour.~Donafenib: Treatment should begin the day after the completion of the first HAIC, with an initial dose of 0.1g bid p.o.. The investigator may increase the dose to 0.2g bid depending on the patient's condition.~Sintilimab: Administration may begin after the first HAIC, 200 mg iv Q3W. After surgery, continued sintilimab and donafenib for 6 cycles."

DRUG

Sintilimab and Donafenib

Donafenib: an initial dose of 0.1g bid p.o. The investigator may increase the dose to 0.2g bid depending on the patient's condition. Sintilimab: 200 mg iv Q3W. After surgery, continued sintilimab and donafenib for 6 cycles.

PROCEDURE

Surgery

After surgery, received sintilimab and donafenib for 6 cycles.

Trial Locations (3)

200062

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

300000

NOT_YET_RECRUITING

TianJin Medical University Cancer Institute & Hospital, Tianjin

350014

NOT_YET_RECRUITING

Fujian Cancer Hospital, Fuzhou

All Listed Sponsors
lead

Fudan University

OTHER