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Trial Title:
Liver Cancer Immunotherapy: Placebo-controlled Clinical Trial of Hepcortespenlisimut-L
NCT ID:
NCT02232490
Condition:
Hepatocellular Carcinoma
HCC
Liver Cancer
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Conditions: Keywords:
AFP
alpha-fetoprotein
cancer vaccine
cirrhosis
hepatitis
HCC
hepatocellular carcinoma
immunotherapy
liver tumor
Cholangiocarcinoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Biological
Intervention name:
hepcortespenlisimut-L
Description:
hepcortespenlisimut-L (V5) is given in experimental arm
Arm group label:
hepcortespenlisimut-L
Other name:
V5
Intervention type:
Biological
Intervention name:
Placebo
Arm group label:
placebo
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.
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.
Criteria for eligibility:
Criteria:
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.
-
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Immunitor LLC
Address:
City:
Ulaanbaatar
Zip:
14400
Country:
Mongolia
Status:
Recruiting
Contact:
Last name:
aldar Bourinbaiar, MD
Phone:
97688094463
Email:
immunitor@gmail.com
Contact backup:
Last name:
Aldar Bourinbaiar, MD
Email:
aldar@immunitor.com
Investigator:
Last name:
Chinburen Jigjidsuren, MD
Email:
Principal Investigator
Facility:
Name:
Immunitor LLC
Address:
City:
Ulaanbaatar
Country:
Mongolia
Status:
Recruiting
Contact:
Last name:
Aldar Bourinbaiar, MD
Phone:
97695130306
Email:
aldar@immunitor.com
Contact backup:
Last name:
Marina Tarakanovskaya, MD
Email:
marinatarakanovskaya@yahoo.com
Investigator:
Last name:
Chinburen Jigjidsuren, MD
Email:
Principal Investigator
Start date:
January 2015
Completion date:
December 2019
Lead sponsor:
Agency:
Immunitor LLC
Agency class:
Industry
Source:
Immunitor LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02232490
http://www.prweb.com/releases/2014/06/prweb11965485.htm
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4649454/
