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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT00867750
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients, aged ≥ 18 years
* Unequivocal diagnosis of primary HCC (confirmed by biopsy/histology or EASL criteria)
* Tumour characteristics as follows:
* Not more than 5 lesions
* If single, maximal diameter ≤ 10 cm
* If multiple, sum of maximal diameters ≤ 15 cm
* Lesions satellite to primary tumour of less than 1 cm in maximal diameter are not included
* At least one quantifiable lesion on hepatic MRI
* Preserved liver function, corresponding to Child-Pugh class ≤ B-7
* ECOG performance status ≤ 2
* Life expectancy ≥ 12 weeks
* Female patients of childbearing potential must have a negative pregnancy test prior to inclusion in the trial and male and female patients must agree to use an effective contraceptive method for the duration of the trial.
* Willing and able to provide written informed consent
Exclusion Criteria:
* Patients expected to undergo surgery (resection or transplantation) within the 24-week period after randomisation.
* Ascites, which is detectable on physical examination or clinically symptomatic (but patients having ascites discovered by imaging only should not be excluded).
* Serum transaminases \> 5 x ULN
* Lung shunt \> 20%
* Extrahepatic disease
* Moderate to severe portal hypertension, as evidenced by any of the following criteria (occurring in spite of using common criteria for prophylactic treatment and therapy):
* History of variceal haemorrhage in past 2 years
* History of hepatic encephalopathy
* Platelets \< 50.000 /ml
* WBC \< 3.000 / ml
* Previous TIPSS procedure
* Portal vein occlusion or hepatofugal flow.
* Impaired liver function
* Total serum bilirubin \> 2.0 mg / dL
* Serum albumin \< 3.0 g /dl
* creatinine \> 2 mg / dL
* Chemotherapy or other experimental therapy within preceding 4 weeks
* Previous TAE / TACE
* Previous radiation therapy to liver or lungs
* Contraindications for angiography (severe peripheral vascular disease or uncorrectable bleeding diathesis)
* Anatomical variants apparent on 99mTc-MAA scan precluding safe administration of RE
* Any decompensated concomitant disease
* Female patients who are pregnant, breast-feeding, or pre-menopausal and not practising efficient contraceptive method (hormonal contraceptive, intra-uterine device)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00867750
Study Brief:
Protocol Section:
NCT00867750