Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT00562666
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00562666
Study Brief:
Protocol Section:
NCT00562666