NCT06609876

Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC

Thermal Ablation Combined With Low-dose Donafinib for Early Recurrent Hepatocellular Carcinoma: a Multicenter Prospective Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study intends to evaluate the efficacy and safety of low-dose adjuvant donafenib after thermal ablation for early recurrent HCC within Milan criteria.

Detailed description

Thermal ablation is available as the major curative treatments for early-stage recurrent HCC. Donafenib was inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. No study has evaluated low-dose donafenib as adjuvant therapy after thermal ablation. There needs further investigation to explore the efficacy and safety of the combination treatment. Thus, the investigators carried out this prospective, randomized, open-label, phase II trial study to find out it.

Conditions

• Hepatocellular Carcinoma
• Microwave Ablation
• Donafenib
• Recurrent Tumor

Interventions

Type	Name	Description
PROCEDURE	Thermal ablation	Thermal ablation of tumors
DRUG	Donafenib	Donafenib ( 100 mg，bid)

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-10-01
• Completion: 2028-10-01
• First posted: 2024-09-24
• Last updated: 2024-12-03

Locations

1 site across 1 country: China