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 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT00162669
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically proven HCC or alpha-fetoprotein level \> 400 ng/ml together with hypervascular tumor and cirrhosis documented by CT scan or MRI.
* HCC not amenable to curative treatment (resection, transplantation, percutaneous ablation)
* Presence of at least one dimensionally measurable target lesion with largest diameter \>= 2 cm.
* No previous chemoembolization, no previous radiotherapy
* Cancer of the Liver Italian Program (CLIP) score \< 4
* World Health Organization (WHO) performance status of 2 or less
* Life expectancy \>= 3 months.
* Age \>= 18 years.
* Adequate hematologic functions (neutrophil count, at least 1500 per cubic millimeter; platelet count, at least 75,000 per cubic millimetre; Hemoglobin, at least 8 g/dl)
* Adequate liver function (bilirubin, not more than 2 times the upper limit of normal); Adequate renal function (serum creatinine, less than 150 micromol per liter)
* Adequate coagulation function
* Written informed consent
Exclusion Criteria:
* Decompensated cirrhosis (Child-Pugh score \> 7)
* CLIP score \> 4
* Variceal bleeding during the previous 3 months
* Thromboembolic event during the previous 6 months
* Medical condition requiring full dose anticoagulation or anti-platelet drugs
* Abnormal cardiac function with history of ischemic heart disease in the previous 6 months, uncontrolled hypertension, unstable angina, severe cardiac arrhythmia,
* No brain metastasis, No bone metastasis only
* Previous or current malignancies at other sites
* No concomitant antitumor treatment including tamoxifen or somatostatin analogs
* Unstable systemic diseases or active uncontrolled infections.
* Patients (male and female) not using effective contraception if of reproductive potential.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00162669
Study Brief:
Protocol Section:
NCT00162669