Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response
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ClinicalTrials.gov Identifier: NCT01128803 |
Recruitment Status
:
Terminated
First Posted
: May 24, 2010
Last Update Posted
: November 7, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatocellular Carcinoma | Procedure: injection of the cell therapy product | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I/II Multicenter: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | October 2010 |
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Procedure: injection of the cell therapy product
- 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 ]
- Analysis of T lymphocytes [ Time Frame: before each injection ]The secondary aim of the study is to evaluate the anti-AFP immunizing response among patients who received the treatment
- Analysis of T lymphocytes [ Time Frame: 3 weeks after the last injection ]
- Analysis of T lymphocytes [ Time Frame: 3 months after the last injection ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Pre-inclusion Criteria :
- Adults (men or women) aged between 18 and 80 years
- 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.
Inclusion Criteria:
- Negative test for pregnancy or effective contraception
- Patient HIV-, Hep B-, Hep C-, HTLV1 and 2-, Syphilis-
- HLA A 0201 group
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128803
France | |
University Hospital of Angers | |
Angers, France, 49000 | |
CHD La Roche-sur-Yon | |
La Roche-sur-Yon, France, 85000 | |
Nantes University Hospital | |
Nantes, France | |
CH Saint Nazaire | |
Saint Nazaire, France, 44000 |
Principal Investigator: | Jérôme GOURNAY, Dr | CHU Nantes |
Responsible Party: | Nantes University Hospital |
ClinicalTrials.gov Identifier: | NCT01128803 History of Changes |
Other Study ID Numbers: |
06/9-P |
First Posted: | May 24, 2010 Key Record Dates |
Last Update Posted: | November 7, 2013 |
Last Verified: | November 2013 |
Keywords provided by Nantes University Hospital:
Hepatocellular carcinoma immunotherapy alpha foetoprotein dendritic cells |
Additional relevant MeSH terms:
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |