Open Label Trial of Immunotherapy for Advanced Liver Cancer

Liver Cirrhosis Clinical Trial

— HCC  

Official title:

Open Label Trial of Hepcortespenlisimut-L (V5) Immunotherapy for HCC

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02256514
• Other study ID #: IMMV5
• Secondary ID: IMMV5
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: September 2014
• Est. completion date: December 2019

Study information

• Verified date: August 2019
• Source: Immunitor LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Hepcortespenlisimut-L (V5) immunotherapy of HCC in an open label setting with baseline alphafetoprotein serum levels and CT scan image as primary endpoints with monthly follow-up thereafter. Additional endpoints will include blood biochemistry indices and safety monitoring.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: December 2019
• Est. primary completion date: September 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

• HCC
• Liver Cirrhosis

Intervention

Biological:
• Daily oral dose of hepcortespenlisimut-L
Oral therapeutic vaccine, hepcortespenlisimut-L (V5) to be given once-per-day with monthly check-up

Locations

Country	Name	City	State
Mongolia	Immunitor LLC	Ulaanbaatar

Sponsors (2)

Lead Sponsor	Collaborator
Immunitor LLC	Immunitor Inc.

Country where clinical trial is conducted

Mongolia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Effect of hepcortespenlisimut-L (V5) immunotherapy in patients with advanced HCC on blood biochemistry parameters	Monthly blood biochemistry including liver function tests	3 months
Secondary	Effect of hepcortespenlisimut-L (V5) immunotherapy on patients' performance	Monthly evaluation of clinical symptoms as per ECOG performance status	3 months

External 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.