NCT01128803

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_1 hepatocellular-carcinoma

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 24, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 7, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

May 21, 2010

Last Update Submit

November 6, 2013

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomaimmunotherapyalpha foetoproteindendritic cells

Outcome Measures

Primary Outcomes (3)

  • 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.

    3 days after each injection

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

    3 weeks after the last injection

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

    3 months after the last injection

Secondary Outcomes (3)

  • Analysis of T lymphocytes

    before each injection

  • Analysis of T lymphocytes

    3 weeks after the last injection

  • Analysis of T lymphocytes

    3 months after the last injection

Interventions

injection of the cell therapy productPROCEDURE

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

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Negative test for pregnancy or effective contraception
  • Patient HIV-, Hep B-, Hep C-, HTLV1 and 2-, Syphilis-
  • HLA A 0201 group

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital of Angers

Angers, 49000, France

Location

CHD La Roche-sur-Yon

La Roche-sur-Yon, 85000, France

Location

Nantes University Hospital

Nantes, France

Location

CH Saint Nazaire

Saint-Nazaire, 44000, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Jérôme GOURNAY, Dr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2010

First Posted

May 24, 2010

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

November 7, 2013

Record last verified: 2013-11

Locations

FR(4)