NCT06860490View on ClinicalTrials.gov

HAIC Combined with Sintilimab Plus Bevacizumab Biosimilar for Advanced Hepatocellular Carcinoma (TASK-03)

PHASE2RecruitingINTERVENTIONAL
Enrollment

164

Participants

Timeline

Start Date

March 18, 2025

Primary Completion Date

March 10, 2027

Study Completion Date

March 10, 2028

Conditions
Hepatocellular Carcinoma (HCC)
Interventions
DRUG

Sintilimab

Sintilimab will be administered by IV, 200 mg on day 1 of each 21 day cycle.

DRUG

Bevacizumab Biosimilar

Bevacizumab biosimilar will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle.

PROCEDURE

HAIC

FOLFOX regimen (oxaliplatin, 85 mg/m2 from hour 0-2 on day 1; leucovorin, 400 mg/m2 from hour 2-3 on day 1; and fluorouracil, 400 mg/m2 bolus at hour 3 on day 1 and 2,400 mg/m2 over 24 hours) via infusion via the hepatic artery. HAIC was repeated once every 3 weeks for up to four cycles. Sintilimab plus bevacizumab will be administered 1-3 days after HAIC.

Trial Locations (1)

200032

RECRUITING

Zhongshan Hospital, Fudan University, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER