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:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT00517920
Eligibility Criteria:
Inclusion Criteria
* Subject must be greater than or equal to 18 years of age
* Subject must be diagnosed with unresectable or metastatic HCC
* Subjects must have a measurable lesion by RECIST on CT scan in at least one site which has not received radiation
* Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
* No other active malignancy within the past 5 years
Exclusion Criteria
* Subject has received targeted VEGF/PDGF/TKI therapy. Prior Avastin is allowed
* Subject has Child-Pugh grade Class C hepatic impairment
* The subject has proteinuria Common Toxicity Criteria (CTC) grade \> 1 as measured by routine urinalysis or 24 hour urine collection during screening assessment
* Subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure \> 100 mmHg or systolic blood pressure \> 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention
* The subject has a documented left ventricular Ejection Fraction \< 50%
* Subject is receiving therapeutic anticoagulation therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00517920
Study Brief:
Protocol Section:
NCT00517920