Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response
NCT ID: NCT01128803
Last Updated: 2013-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
1 participants
INTERVENTIONAL
2009-10-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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injection of the cell therapy product
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
Eligibility Criteria
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Inclusion Criteria
* Patients affiliated to a social security reimbursement system
* Signed informed consent
* Hepatocellular carcinoma
* At least one dosage with Alpha-foeto-protein ≥ 40 ng/ml
* Patient already treated with chemoembolization, percutaneous destruction (alcohol or radiofrequency), surgery or Sorafenib.
* Negative test for pregnancy or effective contraception
* Patient HIV-, Hep B-, Hep C-, HTLV1 and 2-, Syphilis-
* HLA A 0201 group
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jérôme GOURNAY, Dr
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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University Hospital of Angers
Angers, , France
CHD La Roche-sur-Yon
La Roche-sur-Yon, , France
Nantes University Hospital
Nantes, , France
CH Saint Nazaire
Saint-Nazaire, , France
Countries
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Other Identifiers
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06/9-P
Identifier Type: -
Identifier Source: org_study_id