drugset
drugset / Trial / NCT06812039

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

NCT06812039 ↗

Phase 2 Recruiting 165 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-01-01
Primary completion
2026-12-31
Completion
2028-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Donafenib Small molecule 0.1 g Oral
Subject Donafenib Small molecule 0.2 g Oral
Subject Oxaliplatin Small molecule 85 mg/m2 Other
Subject Raltitrexed Small molecule 2 mg/m2 Other
Subject Sintilimab Monoclonal antibody 200 mg Intravenous

Indications

hepatocellular carcinoma