RecruitingNot ApplicableNCT06609876
Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC
Thermal Ablation Combined With Low-dose Donafinib for Early Recurrent Hepatocellular Carcinoma: a Multicenter Prospective Study
Sponsor
Sun Yat-sen University
Enrollment
108 participants
Start Date
Oct 1, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria8
- 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 Criteria4
- were under 18 years or over 75 years of age;
- primary HCC;
- recurrent HCC beyond Milan criteria;
- RHCC with metastasis or macrovascular tumor thrombus
Interventions
PROCEDUREThermal ablation
Thermal ablation of tumors
DRUGDonafenib
Donafenib ( 100 mg,bid)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06609876
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