Status:
RECRUITING
Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Chinese PLA General Hospital
Conditions:
Hepatocellular Carcinoma
Microwave Ablation
Eligibility:
All Genders
18-75 years
Phase:
NA
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.
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...
Eligibility Criteria
Inclusion
- 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
- were under 18 years or over 75 years of age;
- primary HCC;
- recurrent HCC beyond Milan criteria;
- RHCC with metastasis or macrovascular tumor thrombus
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06609876
Start Date
October 1 2024
End Date
October 1 2028
Last Update
December 3 2024
Active Locations (1)
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1
Chinese PLA General hospital
Beijing, None Selected, China, 100853