Clinical trial NCT01128803: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response
Official title: Phase I/II Multicenter: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
immunotherapy
alpha foetoprotein
dendritic cells
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2010-05-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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) 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 3 days after each injection
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 3 weeks after the last injection
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 3 months after the last injection
Secondary outcomes:
measure: Analysis of T lymphocytes
timeFrame: before each injection
measure: Analysis of T lymphocytes
timeFrame: 3 weeks after the last injection
measure: Analysis of T lymphocytes
timeFrame: 3 months after the last injection
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital of Angers
city: La Roche-sur-Yon
country: France
facility: CHD La Roche-sur-Yon
city: Nantes
country: France
facility: Nantes University Hospital
city: Saint Nazaire
country: France
facility: CH Saint Nazaire
Study officials:
affiliation: Nantes University Hospital
name: Jérôme GOURNAY, Dr
role: PRINCIPAL_INVESTIGATOR
References: