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Open Label Trial of Hepcortespenlisimut-L (V5) Immunotherapy for HCC
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.
Details
| Lead sponsor | Immunitor LLC |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 120 |
| Start date | 2014-09 |
| Completion | 2019-12 |
Conditions
- HCC
- Liver Cirrhosis
Interventions
- Daily oral dose of hepcortespenlisimut-L
Primary outcomes
- Effect of hepcortespenlisimut-L (V5) immunotherapy on serum levels of AFP (IU/ml) compared to baseline — minimum 3 months
monthly check-up of AFP serum levels - Effect of hepcortespenlisimut-L (V5) immunotherapy on tumor size or clearance — minimum 3 months
Comparison of abdominal CT scans at baseline and 3 months later
Countries
Mongolia