Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma; Microwave Ablation; Donafenib; Recurrent Tumor
• Interventions: Procedure: Thermal ablation; Drug: Donafenib

• Registration Number: NCT06609876
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Study Timeline

• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-20
• Study First Posted: 2024-09-24
• Study Start: 2024-10-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-01
• Last Update Posted: 2024-12-03
• Primary Completion: 2026-10-01
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. were aged 18-75 years;
2. had recurrent HCC (RHCC) diagnosed by imaging studies, the first or the second RHCC;
3. RHCC met the Milan criteria, namely single RHCC lesion less than 5 cm in diameter or no more than 3 tumors (each ≤3 cm in diameter);
4. the early RHCC (recurrent time <1 year)
5. patients were unwilling to undergo repeat hepatectomy or liver transplantation;
6. had well-preserved liver function, i.e., Child-Pugh class A or B, and prolonged prothrombin time≤5 s;
7. patients had an Eastern Cooperative Oncology Group performance status score ≤1.
8. Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria

1. were under 18 years or over 75 years of age;
2. primary HCC;
3. recurrent HCC beyond Milan criteria;
4. RHCC with metastasis or macrovascular tumor thrombus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microwave ablation plus Donafenib	Donafenib	Patients accepted thermal ablation (microwave ablation,radiofrequency ablation) plus Donafenib (100mg, bid)
Thermal ablation	Thermal ablation	Patients only accepted thermal ablation (microwave ablation,radiofrequency ablation)
Microwave ablation plus Donafenib	Thermal ablation	Patients accepted thermal ablation (microwave ablation,radiofrequency ablation) plus Donafenib (100mg, bid)

Primary Outcome Measures

Name	Time	Method
Tumor-free survival rate	24 months	Progression was defined as progressive disease after thermal ablation by independent radiologic review according to mRECIST or death from any cause

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	36 months	OS is the length of time from the date of ablation until death from any cause.
Adverse events	36 months	Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.

Trial Locations

Locations (1)

Chinese PLA General hospital; 🇨🇳 Beijing, None Selected, China