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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Thermal ablation of tumors
Donafenib ( 100 mg,bid)
Chinese PLA General hospital
Beijing, None Selected, China
RECRUITINGTumor-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
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