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

February 25, 2019 updated by: Aldar Bourinbaiar, Immunitor LLC

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mongolia
      • Ulaanbaatar, Mongolia
        • Recruiting
        • Immunitor LLC
        • Principal Investigator:
          • Chinburen Jigjidsuren, MD
      • Ulaanbaatar, Mongolia, 14400
        • Recruiting
        • Immunitor LLC
        • Principal Investigator:
          • Chinburen Jigjidsuren, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Biological: Placebo
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 Names:
  • V5

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse effects
Time Frame: 3 months
evaluation of adverse effects if any
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunitor LLC

Investigators

  • Study Director: aldar bourinbaiar, Immunitor LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

September 3, 2014

First Submitted That Met QC Criteria

September 4, 2014

First Posted (Estimate)

September 5, 2014

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Immunitor Hepko-V5
  • IMM05 (Other Identifier: Immunitor)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

DATA TO BE SHARED WITH COLLABORATORS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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