Status:
UNKNOWN
Liver Cancer Immunotherapy: Placebo-controlled Clinical Trial of Hepcortespenlisimut-L
Lead Sponsor:
Immunitor LLC
Conditions:
Hepatocellular Carcinoma
HCC
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 result...
Eligibility Criteria
Inclusion
- 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
- 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.
- \-
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02232490
Start Date
January 1 2015
End Date
December 1 2019
Last Update
February 26 2019
Active Locations (2)
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1
Immunitor LLC
Ulaanbaatar, Mongolia, 14400
2
Immunitor LLC
Ulaanbaatar, Mongolia