Open Label Trial of Immunotherapy for Advanced Liver Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Open Label Trial of Hepcortespenlisimut-L (V5) Immunotherapy for HCC

Conditions
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HCC, Liver Cirrhosis

Intervention / Treatment
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* Biological: Daily oral dose of hepcortespenlisimut-L


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are at least 18 years old and are willing and capable of providing informed consent. Both men and non-pregnant women will be included. HCC diagnosis documented prior to Study Entry by either cytology/histology, CT scan, and AFP serum test higher or equal to 30 IU/ml. All subjects with reproductive potential are advised to utilize effective contraception throughout the course of this study. Health score status at baseline. Agreement to participate in the study and to give at least 3 samples of blood for lab tests. Readily available home or o other address where patient can be found. Exclusion Criteria: Subjects who might have already taken V5 in prior trials and have no baseline data. Those who met inclusion criteria can be retrospectively enrolled. Pregnant or breast-feeding women are excluded. Subjects who have taken other immunomodulatory therapies within 2 months prior to Entry: systemic corticosteroids, immune globulin (IV gamma globulin, IVIG), interferons, interleukins, pentoxifylline (Trental), thalidomide, filgrastim (G-CSF), sargramostim (GM-CSF); dinitrochlorobenzene (DNCB), thymosin alpha 1 (thymosin alpha), thymopentin, inosiplex (Isoprinosine), polyribonucleoside (Ampligen), ditiocarb sodium (Imuthiol), any locally available immune modulators, and any other therapeutic or preventive HCC vaccine. Subjects requiring concurrent participation in another experimental research treatment study, or who received an experimental agent within four weeks prior to Study Entry. Evidence of active or acute cardiac disease, epilepsy, or life-threatening diseases unrelated to HCC. Medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily oral dose of hepcortespenlisimut-L<br>Hepcortespenlisimut-L (V5) (850 mg pill) to be administered once per day for the duration of study | Biological: Daily oral dose of hepcortespenlisimut-L<br>* Oral therapeutic vaccine, hepcortespenlisimut-L (V5) to be given once-per-day with monthly check-up<br>* Other names: V5;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of hepcortespenlisimut-L (V5) immunotherapy on serum levels of AFP (IU/ml) compared to baseline | monthly check-up of AFP serum levels | 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 | minimum 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of hepcortespenlisimut-L (V5) immunotherapy in patients with advanced HCC on blood biochemistry parameters | Monthly blood biochemistry including liver function tests | 3 months | 
| Effect of hepcortespenlisimut-L (V5) immunotherapy on patients' performance | Monthly evaluation of clinical symptoms as per ECOG performance status | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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therapeutic vaccine