NCT06812039

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

HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence: a Prospective, Multicenter, Randomized Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of therapy perioperative treatment with HAIC combined with donafenib and sintilimab (group A)/ donafenib combined with sintilimab (group B) compared with direct surgery (group C) in resectable HCC patients who are at high risk for disease recurrence.

Conditions

• Hepato Cellular Carcinoma (HCC)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-12-31
• Completion: 2028-01-31
• First posted: 2025-02-06
• Last updated: 2025-02-06

Locations

3 sites across 1 country: China