Open Label Trial of Immunotherapy for Advanced Liver Cancer (HCC)

Immunitor

Status and phase

Unknown

Phase 2

Conditions

Liver Cirrhosis

HCC

Treatments

Biological: Daily oral dose of hepcortespenlisimut-L

Study type

Interventional

Funder types

Industry

Identifiers

NCT02256514

IMMV5 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

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.