Hepatocellular CarcinomaPhase 1/2NCT01128803
Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response
A Phase 1/2 study testing injection of the cell therapy product in people with Hepatocellular Carcinoma, run by Nantes University Hospital at 4 sites in France.
Trial summary
The secretion by tumor cells of alpha fetoprotein (AFP) was observed in 50 to 60% of hepatocellular carcinoma. The AFP can be used as a marker for tumor recurrence after treatment and may be considered as a tumor antigen specific for hepatocellular carcinoma.The aim of the project is to use the alpha fetoprotein (AFP)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- injection of the cell therapy product
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1 participants
- Where
- 4 sitesFrance
- Study dates
- Oct 2009to Oct 2010
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Negative test for pregnancy or effective contraception
- Patient HIV-, Hep B-, Hep C-, HTLV1 and 2-, Syphilis-
- HLA A 0201 group
Who cannot join
- Life expectancy < 3 months
- Pregnancy or breast-feeding
- Severe auto-immune disease
- Another malignant tumor except if considered as cured since more than 5 years
- History of uncontrolled psychiatric condition
- Risk factors of Creutzfeldt Jacobs disease
- Decompensated cirrhosis(ascites or Child-Pugh score greater than 8)
- Hepatic transplantation
Trial locations and contacts
4 sites in 1 country.
France4 sites
University Hospital of Angers
Angers, 49000
CHD La Roche-sur-Yon
La Roche-sur-Yon, 85000
Nantes University Hospital
Nantes
CH Saint Nazaire
Saint-Nazaire, 44000
About this study
Official title: Phase I/II Multicenter: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response
The secretion by tumor cells of alpha fetoprotein (AFP) was observed in 50 to 60% of hepatocellular carcinoma. The AFP can be used as a marker for tumor recurrence after treatment and may be considered as a tumor antigen specific for hepatocellular carcinoma.The aim of the project is to use the alpha fetoprotein (AFP) as a tumor antigen and to propose an approach of immunotherapy for hepatocellular carcinoma based on the injection of autologous dendritic cells loaded with specific peptides of AFP.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- injection of the cell therapy product
- Keywords
- Hepatocellular carcinoma, immunotherapy, alpha foetoprotein, dendritic cells
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of the cell therapy productProcedure or surgery
Between D-15 and D-30: Cytapheresis D0: 1st injection of the cell therapy product D21: 2nd injection of the cell therapy product D42: 3rd injection of the cell therapy product and 1 injection of dendritic cells not loaded D45: cutaneous biopsies if induration > 2mm
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
The main aim of this study is to test the absence of toxicity of the injection of autologist dendritic cells loaded with specific peptides of the AFP, for patients with hepatocellular carcinoma and already treated.
Measured: 3 days after each injection
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 3 weeks after the last injection
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 3 months after the last injection
Secondary outcomes (3)
Analysis of T lymphocytes
The secondary aim of the study is to evaluate the anti-AFP immunizing response among patients who received the treatment
Measured: before each injection
Analysis of T lymphocytes
Measured: 3 weeks after the last injection
Analysis of T lymphocytes
Measured: 3 months after the last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 2010
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.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme GOURNAY, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128803
- Sponsor's protocol ID
- 06/9-P
- Status last verified
- Nov 2013
- First submitted
- 21 May 2010
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Multicenter: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response
- ClinicalTrials.gov ID
- NCT01128803
- Acronym / sponsor ID
- 06/9-P
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, immunotherapy, alpha foetoprotein, dendritic cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 May 2010 (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 secretion by tumor cells of alpha fetoprotein (AFP) was observed in 50 to 60% of hepatocellular carcinoma. The AFP can be used as a marker for tumor recurrence after treatment and may be considered as a tumor antigen specific for hepatocellular carcinoma.The aim of the project is to use the alpha fetoprotein (AFP) as a tumor antigen and to propose an approach of immunotherapy for hepatocellular carcinoma based on the injection of autologous dendritic cells loaded with specific peptides of AFP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Negative test for pregnancy or effective contraception
- Patient HIV-, Hep B-, Hep C-, HTLV1 and 2-, Syphilis-
- HLA A 0201 group
Key exclusion criteria (8 listed)
- Life expectancy < 3 months
- Pregnancy or breast-feeding
- Severe auto-immune disease
- Another malignant tumor except if considered as cured since more than 5 years
- History of uncontrolled psychiatric condition
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 |
|---|---|---|
| injection of the cell therapy productBetween D-15 and D-30: Cytapheresis D0: 1st injection of the cell therapy product D21: 2nd injection of the cell therapy product D42: 3rd injection of the cell therapy product and 1 injection of dendritic cells not loaded D45: cutaneous biopsies if induration > 2mm | Procedure or surgery | – |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 3 days after each injection
The main aim of this study is to test the absence of toxicity of the injection of autologist dendritic cells loaded with specific peptides of the AFP, for patients with hepatocellular carcinoma and already treated.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 3 weeks after the last injection
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 3 months after the last injection
3 secondary outcomes
Analysis of T lymphocytes
Time frame: before each injection
Analysis of T lymphocytes
Time frame: 3 weeks after the last injection
Analysis of T lymphocytes
Time frame: 3 months after the last injection
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2013.
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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.
Jérôme GOURNAY, Dr principal investigator
Nantes University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing injection of the cell therapy product in people with Hepatocellular Carcinoma, run by Nantes University Hospital at 4 sites in France.
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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 7 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was stopped early. 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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 3 days after each injection). The study lists 3 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 7 Nov 2013; AzTrials last refreshed its copy on 8 Nov 2026.