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Immunotherapy of Hepatocellular Carcinoma by Hepatic Intra Arterial Injection of Autologous Gamma-delta T Lymphocytes: A Phase I Study


Phase 1
18 Years
N/A
Not Enrolling
Both
Hepatocellular Carcinoma

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Trial Information

Immunotherapy of Hepatocellular Carcinoma by Hepatic Intra Arterial Injection of Autologous Gamma-delta T Lymphocytes: A Phase I Study


Inclusion Criteria:



- 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

Non inclusion Criteria:

- 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

- Leucocytes < 3000/mm3 or neutrophils < 1500/mm3

- Platelets < 80000/mm3

- Serum creatinine > 110 µmol/L

- Bilirubin > 35 µmol/L

- AST, ALT, alkaline phosphatase > 5N

- Current immunosuppressive treatment

- Impossibility to comply with scheduled follow-up

- Anatomical situation not permitting the selective injection of the product of cell
therapy

- Pregnant or breastfeeding woman, or not using adequate effective contraceptive method

Exclusion Criterion:

- Insufficient number of gamma delta lymphocytes after expansion

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Within 14 days after treatment

Safety Issue:

Yes

Principal Investigator

Jean-Luc RAOUL, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CRLCC Eugène Marquis, Rennes

Authority:

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

Study ID:

ID RCB 2007-A00249-44

NCT ID:

NCT00562666

Start Date:

February 2008

Completion Date:

January 2009

Related Keywords:

  • Hepatocellular Carcinoma
  • cell therapy
  • T lymphocytes
  • hepatic intra-arterial injection
  • Carcinoma
  • Carcinoma, Hepatocellular

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