Clinical trial · Interventional
Open Label Trial of Immunotherapy for Advanced Liver Cancer
Open Label Trial of Hepcortespenlisimut-L (V5) Immunotherapy for HCC
NCT02256514CI-TRIAL-00040328HCCunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HCC | — | UNRESOLVED | — |
| Liver Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daily oral dose of hepcortespenlisimut-L | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Daily oral dose of hepcortespenlisimut-L
- description
- Hepcortespenlisimut-L (V5) (850 mg pill) to be administered once per day for the duration of study
- interventionNames
- Biological: Daily oral dose of hepcortespenlisimut-L
Primary outcomes (2)
- measure
- Effect of hepcortespenlisimut-L (V5) immunotherapy on serum levels of AFP (IU/ml) compared to baseline
- timeFrame
- minimum 3 months
- description
- monthly check-up of AFP serum levels
- measure
- Effect of hepcortespenlisimut-L (V5) immunotherapy on tumor size or clearance
- timeFrame
- minimum 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.