This phase II study is to evaluate the efficacy of the adjuvant immunotherapy after curative-intent ablation for recurrent hepatocarcinoma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
toripalimab treatment (240mg intravenously every 3 weeks) started on day 3 after ablation for six months
The ablation operation was performed under local or compound anesthesia and guided by ultrasonography (US) or computed tomography (CT). To ensure complete destruction of the tumor, the ablation area must exceed the tumor boundary 1.0 cm.
Xiangya Hospital, Central South University
Changsha, Hunan, China
RECRUITINGDisease-free survival
Disease-free survival was defined as the interval from the date of randomization to date of detection new recurrent disease
Time frame: up to 3 years until study closed
Overall survival
Overall survival (OS) was defined as the interval from the date of randomization to death or study closed
Time frame: up to 3 years until study closed
Number of participants with adverse events
Evaluation will be done using NCI-CTCAE (version 4.03).
Time frame: Up to approximately 3 years
Predictive Biomarkers
Tissue and blood biomarkers in including PD-L1 expression, tumor mutation burden defined as the number of non-inherited mutations per million bases of investigated genomic sequence
Time frame: Up to approximately 3 years
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