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Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response

Primary Purpose

Hepatocellular Carcinoma

Status
Terminated
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
injection of the cell therapy product
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, immunotherapy, alpha foetoprotein, dendritic cells

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Angers
  • CHD La Roche-sur-Yon
  • Nantes University Hospital
  • CH Saint Nazaire

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Analysis of T lymphocytes
The secondary aim of the study is to evaluate the anti-AFP immunizing response among patients who received the treatment
Analysis of T lymphocytes
Analysis of T lymphocytes

Full Information

First Posted
May 21, 2010
Last Updated
November 6, 2013
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01128803
Brief Title
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

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular carcinoma, immunotherapy, alpha foetoprotein, dendritic cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
injection of the cell therapy product
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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.
Time Frame
3 days after each injection
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
3 weeks after the last injection
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
3 months after the last injection
Secondary Outcome Measure Information:
Title
Analysis of T lymphocytes
Description
The secondary aim of the study is to evaluate the anti-AFP immunizing response among patients who received the treatment
Time Frame
before each injection
Title
Analysis of T lymphocytes
Time Frame
3 weeks after the last injection
Title
Analysis of T lymphocytes
Time Frame
3 months after the last injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérôme GOURNAY, Dr
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
CHD La Roche-sur-Yon
City
La Roche-sur-Yon
ZIP/Postal Code
85000
Country
France
Facility Name
Nantes University Hospital
City
Nantes
Country
France
Facility Name
CH Saint Nazaire
City
Saint Nazaire
ZIP/Postal Code
44000
Country
France

12. IPD Sharing Statement

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Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response

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