NCT02232490

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at below P25 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Jan 2015

Typical duration for phase_3 hepatocellular-carcinoma

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

4.8 years

First QC Date

September 3, 2014

Last Update Submit

February 25, 2019

Conditions

Hepatocellular CarcinomaHCCLiver Cancer

Keywords

AFPalpha-fetoproteincancer vaccinecirrhosishepatitisHCChepatocellular carcinomaimmunotherapyliver tumorCholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

  • changes in plasma AFP

    Changes in plasma AFP levels at monthly intervals

    3 months

Secondary Outcomes (1)

  • CT scan

    3 months

Other Outcomes (1)

  • adverse effects

    3 months

Study Arms (2)

hepcortespenlisimut-L

EXPERIMENTAL

Experimental placebo-controlled clinical of hepcortespenlisimut-L (V5) therapeutic vaccine against HCC

Biological: hepcortespenlisimut-L

placebo

PLACEBO COMPARATOR

placebo

Biological: Placebo

Interventions

hepcortespenlisimut-LBIOLOGICAL

hepcortespenlisimut-L (V5) is given in experimental arm

Also known as: V5
hepcortespenlisimut-L
PlaceboBIOLOGICAL
placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. -

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Immunitor LLC

Ulaanbaatar, 14400, Mongolia

RECRUITING

Immunitor LLC

Ulaanbaatar, Mongolia

RECRUITING

Related Links

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver NeoplasmsFibrosisHepatitisCholangiocarcinoma

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • aldar bourinbaiar

    Immunitor LLC

    STUDY DIRECTOR

Central Study Contacts

Aldar Bourinbaiar, MD/PhD

CONTACT

+97695130306immunitor@gmail.com

Galyna kutsyna, MD

CONTACT

9053222kutsynagalyna@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

September 3, 2014

First Posted

September 5, 2014

Study Start

January 1, 2015

Primary Completion

November 1, 2019

Study Completion

December 1, 2019

Last Updated

February 26, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

DATA TO BE SHARED WITH COLLABORATORS

Locations

MO(2)