Liver Cancer Immunotherapy: Placebo-controlled Clinical Trial of Hepcortespenlisimut-L

Study Overview
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Brief Summary
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Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular carcinoma.

Detailed Description
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Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular carcinoma. The results will be compared to placebo. The trial duration is 3 months and will consist of one stage with baseline laboratory evaluation including AFP levels with follow-up at monthly intervals. In addition pre-entry abdominal CT scan and end-study CT scan will be preformed. The clinical evaluation will be quantified according to special performance questionnaire.

Official Title
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Phase III Randomized, Placebo-controlled Clinical Trial of Hepcortespenlisimut-L (Hepko-V5) Versus Placebo in Patients With Advanced Hepatocellular Carcinoma (HCC)

Conditions
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Hepatocellular Carcinoma, HCC, Liver Cancer

Intervention / Treatment
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* Biological: hepcortespenlisimut-L
* Biological: Placebo


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hepcortespenlisimut-L<br>Experimental placebo-controlled clinical of hepcortespenlisimut-L (V5) therapeutic vaccine against HCC | Biological: hepcortespenlisimut-L<br>* hepcortespenlisimut-L (V5) is given in experimental arm<br>* Other names: V5;|
| Placebo Comparator: placebo<br>placebo | Biological: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in plasma AFP | Changes in plasma AFP levels at monthly intervals | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT scan | changes in tumor size/mumber at 3 months compared to baseline | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AFP, alpha-fetoprotein, cancer vaccine, cirrhosis, hepatitis, HCC, hepatocellular carcinoma, immunotherapy, liver tumor, Cholangiocarcinoma