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 @ 2:09 PM
Ignite Modification Date:
2025-12-24 @ 2:09 PM
NCT ID:
NCT00351195
Eligibility Criteria:
Inclusion Criteria:
* Histologically verified intra- or extrahepatic inoperable hepatocellular carcinoma or hyperdense liver lesion at computed tomography and concurrent elevated alpha-feto-protein \> 400 ng/ml
* PS 0-2
* Age 18-75
* Life expectancy \> 12 weeks
* Normal bone marrow function (neutrophiles \> 1,5 x 109/l and platelets \> 100 x 109/l)
* Bilirubin \< 2 x UNL
* Transaminases \< 3 x UNL
* Normal renal function, Cr-EDTA clearance \> 50 ml/min
* No chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
* No uncontrolled, severe concurrent medical disease
* Fertile women must have a negative pregnancy test
* Fertile women must use adequate contraceptives during and 3 months after trial exposure
* Signed informed consent
Exclusion Criteria:
* Chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
* Experimental therapy \< 8 weeks prior to inclusion
* Known DPD-deficiency
* Known neuropathy
* Uncontrolled, severe concurrent medical disease
* Prior malignancy during the last 5 years, except for non-melanoma skin cancer and carcinoma in situ cervix uteri.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00351195
Study Brief:
Protocol Section:
NCT00351195