Open Label Trial of Immunotherapy for Advanced Liver Cancer

NCT02256514 | Unknown Phase 2 DMC

• 1 other identifier: IMMV5
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate daily dosing of oral immunotherapy hepcortespenlisimut-L (V5) in patients with advanced stage of HCC not amenable to surgical intervention or with recurrent tumor after surgery.

Conditions

HCC; Liver Cirrhosis

Keywords

therapeutic vaccine

Outcome Measures

Primary Outcomes (2)

• Effect of hepcortespenlisimut-L (V5) immunotherapy on serum levels of AFP (IU/ml) compared to baseline

  monthly check-up of AFP serum levels

  minimum 3 months

• Effect of hepcortespenlisimut-L (V5) immunotherapy on tumor size or clearance

  Comparison of abdominal CT scans at baseline and 3 months later

  minimum 3 months

Secondary Outcomes (2)

• Effect of hepcortespenlisimut-L (V5) immunotherapy in patients with advanced HCC on blood biochemistry parameters

  3 months

• Effect of hepcortespenlisimut-L (V5) immunotherapy on patients' performance

  3 months

Study Arms (1)

Daily oral dose of hepcortespenlisimut-L

EXPERIMENTAL

Hepcortespenlisimut-L (V5) (850 mg pill) to be administered once per day for the duration of study

Biological: Daily oral dose of hepcortespenlisimut-L

Interventions

Daily oral dose of hepcortespenlisimut-L BIOLOGICAL

Oral therapeutic vaccine, hepcortespenlisimut-L (V5) to be given once-per-day with monthly check-up

Also known as: V5

Daily oral dose of hepcortespenlisimut-L

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 might have already taken V5 in prior trials and have no baseline data.
• 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.

Sponsors & Collaborators

• Immunitor LLC: lead
• Immunitor Inc.: collaborator

Study Sites (1)

Immunitor LLC

Ulaanbaatar, Mongolia

Location

Related Links

• press release concerning preliminary results
• Tarakanovskaya, M. G., Chinburen, J., Purevsuren, G., Munkhzaya, C., Batchuluun, P., Bat-Ireedui, P., … Bourinbaiar, A. S. (2015). Immunotherapy of liver cancer with hepcortespenlisimut-L: open-label Phase II clinical study in patients with advanced HCC.

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aldar Bourinbaiar, MD/PhD

  Immunitor LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: October 3, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 30, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

MO (1)