Immunotherapy of Hepatocellular Carcinoma With Gamma Delta T Cells

Phase 1TerminatedNCT00562666

Rennes University Hospital2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

T gamma delta lymphocytesOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Rennes, France

Département d'Oncologie Médicale - CRLCC Eugène Marquis

Rennes, France

Service de Chirugie Viscérale - Hôpital de Pontchaillou

Rennes, France

Outcomes

Primary Outcomes

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

Time frame: Within 14 days after treatment

Secondary Outcomes

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.

Time frame: 3 months

Data from ClinicalTrials.gov

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