Liver Cancer Immunotherapy: Placebo-controlled Clinical Trial of Hepcortespenlisimut-L (Hepko-V5)

Immunitor

Status and phase: Unknown; Phase 3

Conditions: Hepatocellular Carcinoma; Liver Cancer; HCC

Treatments: Biological: Placebo; Biological: hepcortespenlisimut-L

Study type: Interventional

Funder types: Industry

Identifiers

NCT02232490

IMM05 (Other Identifier)

Immunitor Hepko-V5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

hepcortespenlisimut-L

Experimental group

Description:

Experimental placebo-controlled clinical of hepcortespenlisimut-L (V5) therapeutic vaccine against HCC

Treatment:

Biological: hepcortespenlisimut-L

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Biological: Placebo