Hepatocellular CarcinomaPhase 3Hepko-V5NCT02232490
Liver Cancer Immunotherapy: Placebo-controlled Clinical Trial of Hepcortespenlisimut-L
A Phase 3 study testing hepcortespenlisimut-L in people with Hepatocellular Carcinoma and HCC, run by Immunitor LLC at 2 sites in Mongolia.
Trial summary
Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, HCC, Liver Cancer
- What is being tested?
- hepcortespenlisimut-L
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesMongolia
- Study dates
- Jan 2015to Dec 2019
- Phase
- Phase 3
- 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
2 sites in 1 country.
Mongolia2 sites, 2 recruiting
- Recruiting
Immunitor LLC
Ulaanbaatar, 14400
aldar Bourinbaiar, MD, 97688094463, immunitor@gmail.com
Aldar Bourinbaiar, MD, aldar@immunitor.com
- Recruiting
Immunitor LLC
Ulaanbaatar
Aldar Bourinbaiar, MD, 97695130306, aldar@immunitor.com
Marina Tarakanovskaya, MD, marinatarakanovskaya@yahoo.com
About this study
Official title: Phase III Randomized, Placebo-controlled Clinical Trial of Hepcortespenlisimut-L (Hepko-V5) Versus Placebo in Patients With Advanced Hepatocellular Carcinoma (HCC)
Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular carcinoma.
Read the detailed description
Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular carcinoma. The results will be compared to placebo. The trial duration is 3 months and will consist of one stage with baseline laboratory evaluation including AFP levels with follow-up at monthly intervals. In addition pre-entry abdominal CT scan and end-study CT scan will be preformed. The clinical evaluation will be quantified according to special performance questionnaire.
- Conditions
- Hepatocellular Carcinoma, HCC, Liver Cancer
- Being tested
- hepcortespenlisimut-L, Placebo
- Keywords
- AFP, alpha-fetoprotein, cancer vaccine, cirrhosis, hepatitis, HCC, hepatocellular carcinoma, immunotherapy, liver tumor, Cholangiocarcinoma
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Fibrosis, Hepatitis, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepcortespenlisimut-LBiological
Also called V5
hepcortespenlisimut-L (V5) is given in experimental arm
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| hepcortespenlisimut-L | Experimental | Experimental placebo-controlled clinical of hepcortespenlisimut-L (V5) therapeutic vaccine against HCC Receives: Biological: hepcortespenlisimut-L |
| placebo | Placebo comparator | placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in plasma AFP
Changes in plasma AFP levels at monthly intervals
Measured: 3 months
Secondary outcomes (1)
CT scan
changes in tumor size/mumber at 3 months compared to baseline
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 posted5 Sep 2014 (estimated)
- Study startJan 2015
- Primary completionNov 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 Hepatocellular CarcinomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunitor LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Aldar Bourinbaiar, Immunitor LLC
- Investigators
- aldar bourinbaiar, Study director, Immunitor LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232490
- Sponsor's protocol ID
- Immunitor Hepko-V5
- Other IDs
- IMM05
- Acronym
- Hepko-V5
- Status last verified
- Feb 2019
- First submitted
- 3 Sep 2014
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: DATA TO BE SHARED WITH COLLABORATORS
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized, Placebo-controlled Clinical Trial of Hepcortespenlisimut-L (Hepko-V5) Versus Placebo in Patients With Advanced Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT02232490
- Acronym / sponsor ID
- Hepko-V5 / Immunitor Hepko-V5
- Conditions
- Hepatocellular Carcinoma, HCC, Liver Cancer
- Keywords
- AFP, alpha-fetoprotein, cancer vaccine, cirrhosis, hepatitis, HCC, hepatocellular carcinoma, immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Immunitor LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Sep 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.
Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular carcinoma.
Detailed description
Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular carcinoma. The results will be compared to placebo. The trial duration is 3 months and will consist of one stage with baseline laboratory evaluation including AFP levels with follow-up at monthly intervals. In addition pre-entry abdominal CT scan and end-study CT scan will be preformed. The clinical evaluation will be quantified according to special performance questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hepcortespenlisimut-L | Experimental | Biological: hepcortespenlisimut-LExperimental placebo-controlled clinical of hepcortespenlisimut-L (V5) therapeutic vaccine against HCC |
| placebo | Placebo comparator | Biological: Placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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.
- Readily available home or o other address where patient can be found. -
Key exclusion criteria (5 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.
- 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.
- -
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 |
|---|---|---|
| hepcortespenlisimut-LAlso: V5hepcortespenlisimut-L (V5) is given in experimental arm | Biological | hepcortespenlisimut-L |
| Placebo | Biological | placebo |
Primary outcome
changes in plasma AFP
Time frame: 3 months
Changes in plasma AFP levels at monthly intervals
1 secondary outcome
CT scan
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 26 Feb 2019.
- Interim Phase II trial outcomeLink provided by the sponsor.
- Phase II results abstractLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. DATA TO BE SHARED WITH COLLABORATORS
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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 study director
Immunitor LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hepcortespenlisimut-L in people with Hepatocellular Carcinoma and HCC, run by Immunitor LLC at 2 sites 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 5 inclusion and 5 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Aldar Bourinbaiar, MD/PhD (+97695130306, immunitor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in plasma AFP (time frame: 3 months). 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 26 Feb 2019.