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Phase I/II Multicenter: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response


Phase 1/Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

Phase I/II Multicenter: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Outcome Description:

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.

Outcome Time Frame:

3 days after each injection

Safety Issue:

Yes

Principal Investigator

Jérôme GOURNAY, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Nantes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

06/9-P

NCT ID:

NCT01128803

Start Date:

October 2009

Completion Date:

April 2012

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular carcinoma
  • immunotherapy
  • alpha foetoprotein
  • dendritic cells
  • Carcinoma
  • Carcinoma, Hepatocellular

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