Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC

Recruiting now · Not applicable

Conditions studied: Hepatocellular Carcinoma, Microwave Ablation, Donafenib, Recurrent Tumor

In brief

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

Key facts

Study ID

NCT06609876

Run by

Sun Yat-sen University

People needed

108

Starts

2024-10-01

Expected to finish

2028-10-01

Last updated by the study team

2024-12-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Chinese PLA General hospital — Beijing, None Selected, China (enrolling)

Full record on ClinicalTrials.gov

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