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Clinical Trials in China / NCT06609876
Recruiting Not applicable

Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC

NCT06609876 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Not applicable
Started
2024-10-01
Last updated
2024-12-03

Condition(s) studied

Hepatocellular CarcinomaMicrowave AblationDonafenibRecurrent Tumor

Investigational drug(s) / intervention(s)

Thermal ablationDonafenib

Thermal ablation: Thermal ablation of tumors

Donafenib: Donafenib ( 100 mg,bid)

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Chinese PLA General hospital Beijing None Selected Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06609876 on ClinicalTrials.gov ↗ ← All trials in China