Hepatocellular Carcinoma
Conditions
Keywords
cell therapy, T lymphocytes, hepatic intra-arterial injection
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.
Interventions
OTHERT gamma delta lymphocytes
Single hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes
Sponsors
Innate Pharma
Rennes University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed