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Liver Cancer Immunotherapy: Placebo-controlled Clinical Trial of Hepcortespenlisimut-L (Hepko-V5)

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ClinicalTrials.gov Identifier: NCT02232490
Recruitment Status : Recruiting
First Posted : September 5, 2014
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Aldar Bourinbaiar, Immunitor LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma HCC Liver Cancer Biological: hepcortespenlisimut-L Biological: Placebo Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase III Randomized, Placebo-controlled Clinical Trial of Hepcortespenlisimut-L (Hepko-V5) Versus Placebo in Patients With Advanced Hepatocellular Carcinoma (HCC)
Actual Study Start Date : January 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: hepcortespenlisimut-L
Experimental placebo-controlled clinical of hepcortespenlisimut-L (V5) therapeutic vaccine against HCC
Biological: hepcortespenlisimut-L
hepcortespenlisimut-L (V5) is given in experimental arm
Other Name: V5

Placebo Comparator: placebo
placebo
Biological: Placebo



Primary Outcome Measures :
  1. changes in plasma AFP [ Time Frame: 3 months ]
    Changes in plasma AFP levels at monthly intervals


Secondary Outcome Measures :
  1. CT scan [ Time Frame: 3 months ]
    changes in tumor size/mumber at 3 months compared to baseline


Other Outcome Measures:
  1. adverse effects [ Time Frame: 3 months ]
    evaluation of adverse effects if any



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232490


Contacts
Contact: Aldar Bourinbaiar, MD/PhD +97695130306 immunitor@gmail.com
Contact: Galyna kutsyna, MD 9053222 kutsynagalyna@yahoo.com

Locations
Mongolia
Immunitor LLC Recruiting
Ulaanbaatar, Mongolia, 14400
Contact: aldar Bourinbaiar, MD    97688094463    immunitor@gmail.com   
Contact: Aldar Bourinbaiar, MD       aldar@immunitor.com   
Principal Investigator: Chinburen Jigjidsuren, MD         
Immunitor LLC Recruiting
Ulaanbaatar, Mongolia
Contact: Aldar Bourinbaiar, MD    97695130306    aldar@immunitor.com   
Contact: Marina Tarakanovskaya, MD       marinatarakanovskaya@yahoo.com   
Principal Investigator: Chinburen Jigjidsuren, MD         
Sponsors and Collaborators
Immunitor LLC
Investigators
Study Director: aldar bourinbaiar Immunitor LLC

Additional Information:
Responsible Party: Aldar Bourinbaiar, Investigator, Immunitor LLC
ClinicalTrials.gov Identifier: NCT02232490     History of Changes
Other Study ID Numbers: Immunitor Hepko-V5
IMM05 ( Other Identifier: Immunitor )
First Posted: September 5, 2014    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: DATA TO BE SHARED WITH COLLABORATORS

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aldar Bourinbaiar, Immunitor LLC:
AFP
alpha-fetoprotein
cancer vaccine
cirrhosis
hepatitis
HCC
hepatocellular carcinoma
immunotherapy
liver tumor
Cholangiocarcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases