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

Hepatocellular Carcinoma Clinical Trial

— Hepko-V5  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02232490
• Other study ID #: Immunitor Hepko-V5
• Secondary ID: IMM05
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2015
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: Immunitor LLC
• Contact: Aldar Bourinbaiar, MD/PhD
• Phone: +97695130306
• Email: immunitor[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• HCC
• Hepatocellular Carcinoma
• Liver Cancer
• Liver Neoplasms

Intervention

Biological:
• hepcortespenlisimut-L
hepcortespenlisimut-L (V5) is given in experimental arm
• Placebo

Locations

Country	Name	City	State
Mongolia	Immunitor LLC	Ulaanbaatar
Mongolia	Immunitor LLC	Ulaanbaatar

Sponsors (1)

Lead Sponsor	Collaborator
Immunitor LLC

Country where clinical trial is conducted

Mongolia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse effects	evaluation of adverse effects if any	3 months
Primary	changes in plasma AFP	Changes in plasma AFP levels at monthly intervals	3 months
Secondary	CT scan	changes in tumor size/mumber at 3 months compared to baseline	3 months

External Links

•   Interim Phase II trial outcome
•   Phase II results abstract