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Liver Cancer Immunotherapy: Placebo-controlled Clinical Trial of Hepcortespenlisimu (V5)
Conditions
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
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Intervention
Name: hepcortespenlisimut-L
Type: Biological
Name: Placebo
Type: Biological
Overall Status
Recruiting
Summary
Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic benefit of hepcortespenlisimu (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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
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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.
-
Location
National Cancer Center
Ulaanbaatar, Mongolia
Status: Recruiting
Contact: Chinburen Jigjidsuren, MD - 97688094463 - chburen@hotmail.com
Start Date
January 2015
Completion Date
December 2015
Sponsors
Lisichansk Regional Tuberculosis Dispensary
Source
Lisichansk Regional Tuberculosis Dispensary
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page