Open Label Trial of Immunotherapy for Advanced Liver Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2019-12-31

Brief Summary

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The purpose of this study is to evaluate daily dosing of oral immunotherapy hepcortespenlisimut-L (V5) in patients with advanced stage of HCC not amenable to surgical intervention or with recurrent tumor after surgery.

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Detailed Description

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Hepcortespenlisimut-L (V5) immunotherapy of HCC in an open label setting with baseline alphafetoprotein serum levels and CT scan image as primary endpoints with monthly follow-up thereafter. Additional endpoints will include blood biochemistry indices and safety monitoring.

Conditions

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HCC Liver Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Daily oral dose of hepcortespenlisimut-L

Hepcortespenlisimut-L (V5) (850 mg pill) to be administered once per day for the duration of study

Group Type EXPERIMENTAL

Daily oral dose of hepcortespenlisimut-L

Intervention Type BIOLOGICAL

Oral therapeutic vaccine, hepcortespenlisimut-L (V5) to be given once-per-day with monthly check-up

Interventions

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Daily oral dose of hepcortespenlisimut-L

Oral therapeutic vaccine, hepcortespenlisimut-L (V5) to be given once-per-day with monthly check-up

Intervention Type BIOLOGICAL

Other Intervention Names

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V5

Eligibility Criteria

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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.

* 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.