NCT00562666

Brief Summary

For most patients with hepatocellular carcinoma, surgery or other curative procedures are not possible and only palliative measures could be applied (chemoembolization, targeted drugs, best supportive cares, etc). In the ICAR study, increasing doses of a cell therapy product will be evaluated in patients in a palliative setting. All patients will have one hepatic intra-arterial injection of immunological cells (gamma-delta T lymphocytes) and will be evaluated for safety.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_1 hepatocellular-carcinoma

Geographic Reach
1 country

3 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

First Submitted

Initial submission to the registry

November 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 22, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

June 22, 2012

Status Verified

June 1, 2012

Enrollment Period

11 months

First QC Date

November 21, 2007

Last Update Submit

June 21, 2012

Conditions

Hepatocellular Carcinoma

Keywords

cell therapyT lymphocyteshepatic intra-arterial injection

Outcome Measures

Primary Outcomes (1)

  • Onset of: thrombosis of hepatic artery, grade 4 liver toxicity, or grade 3 or more allergic, neurological, dermatological, infectious, or respiratory reaction

    Within 14 days after treatment

Secondary Outcomes (1)

  • Onset of clinical, biological signs or images evocative of lymphocyte-induced tumor cytotoxicity and/or of a persistence of gamma-delta T cells in peripheral blood. Tumor response will be evaluated with the RECIST criteria.

    3 months

Study Arms (4)

1

EXPERIMENTAL

Single hepatic intra arterial administration of 500 millions T gamma delta lymphocytes

Other: T gamma delta lymphocytes

2

EXPERIMENTAL

Single hepatic intra arterial administration of 1000 millions T gamma delta lymphocytes

Other: T gamma delta lymphocytes

3

EXPERIMENTAL

Single hepatic intra arterial administration of 2000 millions T gamma delta lymphocytes

Other: T gamma delta lymphocytes

4

EXPERIMENTAL

Single hepatic intra arterial administration of 4000 millions T gamma delta lymphocytes

Other: T gamma delta lymphocytes

Interventions

T gamma delta lymphocytesOTHER

Single hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes

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Eligibility Criteria

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

You may qualify if:

  • Adult over 18
  • Hepatocellular carcinoma histologically proven, with at least one measurable tumor
  • Non operable tumor
  • Alfa foeto protein \> 400 ng/ml
  • Other treatments (surgery, chemoembolization) non indicated
  • Chemoembolization non indicated due to good performance status (WHO 1) or to tumor volume
  • Performance status WHO \< 2
  • Life expectancy \> 3 months
  • Extra hepatic metastases
  • Severe hepatopathy (Child B or C)
  • Virus B or C chronic hepatitis
  • Chronic cardiac failure
  • Uncontrolled severe infectious disease
  • Other cancer, if not considered as cured
  • Positive serology for HIV or HTLV
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unité de Thérapie Cellulaire, Laboratoire de Cytogénétique et Biologie Cellulaire, CHU Rennes

Rennes, 35000, France

Location

Département d'Oncologie Médicale - CRLCC Eugène Marquis

Rennes, 35042, France

Location

Service de Chirugie Viscérale - Hôpital de Pontchaillou

Rennes, 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

  • Jean-Luc RAOUL, MD, PhD

    CRLCC Eugène Marquis, Rennes

    PRINCIPAL INVESTIGATOR

  • Eric BELLISSANT, MD, PhD

    Rennes University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 22, 2007

Study Start

February 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

June 22, 2012

Record last verified: 2012-06

Locations

FR(3)