An interventional study of Thermal ablation and Donafenib in Hepatocellular Carcinoma, Microwave Ablation and Donafenib, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment
This study intends to evaluate the efficacy and safety of low-dose adjuvant donafenib after thermal ablation for early recurrent HCC within Milan criteria.
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 study has evaluated low-dose donafenib as adjuvant therapy after thermal ablation. There needs further investigation to explore the efficacy and safety of the combination treatment. Thus, the investigators carried out this prospective, randomized, open-label, phase II trial study to find out it.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 108 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients only accepted thermal ablation (microwave ablation,radiofrequency ablation)
Procedure: Thermal ablation
Patients accepted thermal ablation (microwave ablation,radiofrequency ablation) plus Donafenib (100mg, bid)
Procedure: Thermal ablation · Drug: Donafenib
Thermal ablation of tumors
Donafenib ( 100 mg，bid)
Tumor-free survival rate
Progression was defined as progressive disease after thermal ablation by independent radiologic review according to mRECIST or death from any cause
Time frame: 24 months
Overall survival (OS)
OS is the length of time from the date of ablation until death from any cause.
Time frame: 36 months
Adverse events
Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.
Time frame: 36 months
Plan to share: No
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