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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)

  • Tumor-free survival rate — 24 months
    Progression was defined as progressive disease after thermal ablation by independent radiologic review according to mRECIST or death from any cause

Trial sites (1)

FacilityCityRegionStatus
Chinese PLA General hospital Beijing None Selected Recruiting

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Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC Starting soon
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Maintenance Immunotherapy With Deferred Salvage Radiotherapy After Response to Chemoimmunotherapy in Recurrent Nasopharyngeal Carcinoma Recruiting

Other trials for the same condition

A Study to Evaluate C-CAR031 in Glypican-3 (GPC3)+ Advanced/Recurrent Hepatocellular Carcinoma (HCC) Active, not recruiting
Deep Learning-Based Multidimensional Body Composition Mapping for Outcome Prediction in HCC Patients Undergoing TACE Recruiting
HAIC (Hepatic Artery Infusion Chemotherapy，HAIC）Plus Sintilimab and Donafenib in the First-line Treatment of Unresectable Hepatocellular Carcinoma Recruiting
Sintilimab Plus Bevacizumab Biosimilar as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma Recruiting
A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma Active, not recruiting
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