Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC

Sun Yat-sen University

Status: Enrolling

Conditions: Donafenib; Microwave Ablation; Hepatocellular Carcinoma; Recurrent Tumor

Treatments: Drug: Donafenib; Procedure: Thermal ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06609876

Liver Projiect1

Details and patient eligibility

About

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

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Thermal ablation

Experimental group

Description:

Patients only accepted thermal ablation (microwave ablation,radiofrequency ablation)

Treatment:

Procedure: Thermal ablation

Microwave ablation plus Donafenib

Experimental group

Description:

Patients accepted thermal ablation (microwave ablation,radiofrequency ablation) plus Donafenib (100mg, bid)

Treatment:

Procedure: Thermal ablation

Drug: Donafenib