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

This is an interventional treatment trial for HCC focused on measuring therapeutic vaccine Read More

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.