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RecruitingNCT06609876

Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC

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Trial Parameters

ConditionHepatocellular Carcinoma
SponsorSun Yat-sen University
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment108
SexALL
Min Age18 Years
Max Age75 Years
Start Date2024-10-01
Completion2026-10-01
Interventions
Thermal ablationDonafenib

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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.

Eligibility Criteria

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

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