The purpose of this study is to evaluate daily dosing of oral immunotherapy hepcortespenlisimut-L (V5) in patients with advanced stage of HCC not amenable to surgical intervention or with recurrent tumor after surgery.
Hepcortespenlisimut-L (V5) immunotherapy of HCC in an open label setting with baseline alphafetoprotein serum levels and CT scan image as primary endpoints with monthly follow-up thereafter. Additional endpoints will include blood biochemistry indices and safety monitoring.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Oral therapeutic vaccine, hepcortespenlisimut-L (V5) to be given once-per-day with monthly check-up
Immunitor LLC
Ulaanbaatar, Mongolia
Effect of hepcortespenlisimut-L (V5) immunotherapy on serum levels of AFP (IU/ml) compared to baseline
monthly check-up of AFP serum levels
Time frame: minimum 3 months
Effect of hepcortespenlisimut-L (V5) immunotherapy on tumor size or clearance
Comparison of abdominal CT scans at baseline and 3 months later
Time frame: minimum 3 months
Effect of hepcortespenlisimut-L (V5) immunotherapy in patients with advanced HCC on blood biochemistry parameters
Monthly blood biochemistry including liver function tests
Time frame: 3 months
Effect of hepcortespenlisimut-L (V5) immunotherapy on patients' performance
Monthly evaluation of clinical symptoms as per ECOG performance status
Time frame: 3 months
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