Clinical Trials /

Liver Cancer Immunotherapy: Placebo-controlled Clinical Trial of Hepcortespenlisimut-L

NCT02232490

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.

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Liver Cancer Immunotherapy: Placebo-controlled Clinical Trial of Hepcortespenlisimut-L
  • Official Title: Phase III Randomized, Placebo-controlled Clinical Trial of Hepcortespenlisimut-L (Hepko-V5) Versus Placebo in Patients With Advanced Hepatocellular Carcinoma (HCC)

Clinical Trial IDs

  • ORG STUDY ID: Immunitor Hepko-V5
  • SECONDARY ID: IMM05
  • NCT ID: NCT02232490

Conditions

  • Hepatocellular Carcinoma
  • HCC
  • Liver Cancer

Interventions

DrugSynonymsArms
hepcortespenlisimut-LV5hepcortespenlisimut-L
Placeboplacebo

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
hepcortespenlisimut-LExperimentalExperimental placebo-controlled clinical of hepcortespenlisimut-L (V5) therapeutic vaccine against HCC
  • hepcortespenlisimut-L
placeboPlacebo Comparatorplacebo
  • Placebo

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.

        -
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:changes in plasma AFP
Time Frame:3 months
Safety Issue:
Description:Changes in plasma AFP levels at monthly intervals

Secondary Outcome Measures

Measure:CT scan
Time Frame:3 months
Safety Issue:
Description:changes in tumor size/mumber at 3 months compared to baseline

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Immunitor LLC

Trial Keywords

  • AFP
  • alpha-fetoprotein
  • cancer vaccine
  • cirrhosis
  • hepatitis
  • HCC
  • hepatocellular carcinoma
  • immunotherapy
  • liver tumor
  • Cholangiocarcinoma

Last Updated

February 25, 2019