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Recruiting NCT06609876

Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC

No phase Interventional Hepatocellular Carcinoma Microwave Ablation Donafenib Recurrent Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thermal ablation, Donafenib.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma, Microwave Ablation, Donafenib, Recurrent Tumor. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Thermal ablation
    Thermal ablation of tumors
  • Drug Donafenib
    Donafenib ( 100 mg，bid)

Primary outcome measures

  • Tumor-free survival rate [Time frame: 24 months]
Secondary outcome measures (2)
  • Overall survival (OS) [Time frame: 36 months]
  • Adverse events [Time frame: 36 months]

Eligibility criteria

Inclusion criteria

  • were aged 18-75 years;
  • had recurrent HCC (RHCC) diagnosed by imaging studies, the first or the second RHCC;
  • 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);
  • the early RHCC (recurrent time <1 year)
  • patients were unwilling to undergo repeat hepatectomy or liver transplantation;
  • had well-preserved liver function, i.e., Child-Pugh class A or B, and prolonged prothrombin time≤5 s;
  • patients had an Eastern Cooperative Oncology Group performance status score ≤1.
  • Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion criteria

  • were under 18 years or over 75 years of age;
  • primary HCC;
  • recurrent HCC beyond Milan criteria;
  • RHCC with metastasis or macrovascular tumor thrombus

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Chinese PLA General hospital — Beijing

Identifiers

NCT: NCT06609876 · Liver Projiect1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗