HCCPhase 2HCCNCT02256514
Open Label Trial of Immunotherapy for Advanced Liver Cancer
A Phase 2 study testing Daily oral dose of hepcortespenlisimut-L in people with HCC and Liver Cirrhosis, run by Immunitor LLC at 1 site in Mongolia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC, Liver Cirrhosis
- What is being tested?
- Daily oral dose of hepcortespenlisimut-L
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteMongolia
- Study dates
- Sep 2014to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Trial of Hepcortespenlisimut-L (V5) Immunotherapy for HCC
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.
Read the detailed 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.
- Conditions
- HCC, Liver Cirrhosis
- Being tested
- Daily oral dose of hepcortespenlisimut-L
- Keywords
- therapeutic vaccine
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily oral dose of hepcortespenlisimut-LBiological
Also called V5
Oral therapeutic vaccine, hepcortespenlisimut-L (V5) to be given once-per-day with monthly check-up
| Study group | Role | What they receive |
|---|---|---|
| Daily oral dose of hepcortespenlisimut-L | Experimental | Hepcortespenlisimut-L (V5) (850 mg pill) to be administered once per day for the duration of study Receives: Biological: Daily oral dose of hepcortespenlisimut-L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of hepcortespenlisimut-L (V5) immunotherapy on serum levels of AFP (IU/ml) compared to baseline
monthly check-up of AFP serum levels
Measured: minimum 3 months
Effect of hepcortespenlisimut-L (V5) immunotherapy on tumor size or clearance
Comparison of abdominal CT scans at baseline and 3 months later
Measured: minimum 3 months
Secondary outcomes (2)
Effect of hepcortespenlisimut-L (V5) immunotherapy in patients with advanced HCC on blood biochemistry parameters
Monthly blood biochemistry including liver function tests
Measured: 3 months
Effect of hepcortespenlisimut-L (V5) immunotherapy on patients' performance
Monthly evaluation of clinical symptoms as per ECOG performance status
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunitor LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Immunitor Inc.
- Responsible party
- Sponsor
- Investigators
- Aldar Bourinbaiar, MD/PhD, Study director, Immunitor LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256514
- Sponsor's protocol ID
- IMMV5
- Other IDs
- IMMV5
- Acronym
- HCC
- Status last verified
- Aug 2019
- First submitted
- 24 Sep 2014
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be shared at study completion
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Trial of Hepcortespenlisimut-L (V5) Immunotherapy for HCC
- ClinicalTrials.gov ID
- NCT02256514
- Acronym / sponsor ID
- HCC / IMMV5
- Conditions
- HCC, Liver Cirrhosis
- Keywords
- therapeutic vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Immunitor LLCIndustry (pharma, biotech, devices)
- Collaborators
- Immunitor Inc.
- Study start
- Sep 2014 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 3 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily oral dose of hepcortespenlisimut-L | Experimental | Biological: Daily oral dose of hepcortespenlisimut-LHepcortespenlisimut-L (V5) (850 mg pill) to be administered once per day for the duration of study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily oral dose of hepcortespenlisimut-LAlso: V5Oral therapeutic vaccine, hepcortespenlisimut-L (V5) to be given once-per-day with monthly check-up | Biological | Daily oral dose of hepcortespenlisimut-L |
Primary outcome
Effect of hepcortespenlisimut-L (V5) immunotherapy on serum levels of AFP (IU/ml) compared to baseline
Time frame: minimum 3 months
monthly check-up of AFP serum levels
Effect of hepcortespenlisimut-L (V5) immunotherapy on tumor size or clearance
Time frame: minimum 3 months
Comparison of abdominal CT scans at baseline and 3 months later
2 secondary outcomes
Effect of hepcortespenlisimut-L (V5) immunotherapy in patients with advanced HCC on blood biochemistry parameters
Time frame: 3 months
Effect of hepcortespenlisimut-L (V5) immunotherapy on patients' performance
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- press release concerning preliminary resultsLink provided by the sponsor.
- Tarakanovskaya, M. G., Chinburen, J., Purevsuren, G., Munkhzaya, C., Batchuluun, P., Bat-Ireedui, P., … Bourinbaiar, A. S. (2015). Immunotherapy of liver cancer with hepcortespenlisimut-L: open-label Phase II clinical study in patients with advanced HCC.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be shared at study completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aldar Bourinbaiar, MD/PhD study director
Immunitor LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daily oral dose of hepcortespenlisimut-L in people with HCC and Liver Cirrhosis, run by Immunitor LLC at 1 site in Mongolia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mongolia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of hepcortespenlisimut-L (V5) immunotherapy on serum levels of AFP (IU/ml) compared to baseline (time frame: minimum 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.