This study intends to evaluate the efficacy and safety of microwave ablation combined lenvatinib simultaneously for recurrent HCC
Microwave ablation (MWA) is available as the major curative treatments for early-stage recurrent HCC. Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. No study has evaluated MWA simultaneously combined Lenvatinib for recurrent HCC. There needs further investigation to explore the efficacy and safety of the combination treatment. Thus, the investigators carried out this randomized, multicenter, prospective trial study to find out it.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
274
only microwave ablation for tumor
lenvatinib (80 mg for body no more than 60kg,120 mg for body weight \>60 kg)
Hunan Provincial People's Hospital
Changsha, Hunan, China
RECRUITINGTumor-free survival rate at 36 months
Progression was defined as progressive disease after microwave ablation by independent radiologic review according to mRECIST or death from any cause
Time frame: 36 months
Over-all survival (OS) rate at 36 months
OS is the length of time from the date of microwave 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: 24 months
Complication rate
Complication was defined as the a disease or sythrome caused by the therapy
Time frame: 36 months
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