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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT00518557
Eligibility Criteria:
Inclusion Criteria:
* Patients with cytologically or histologically documented HCC, who are candidates for TACE
* Child-Pugh Child A or B
* Age \>= 18
* Measurable disease by RECIST criteria;
* Performance status ECOG 0-2
* Previous local therapy completed \> 4 weeks
* Written informed consent signed
* Normal organ and marrow function defined as:
Haematopoietic:
* WBC ≥ 3,000/µlplatelet count \> 80,000/mm3
* haemoglobin \> 9g/dL
* Hepatic: Albumin ≥ 2.8 g/dl.serum total bilirubin ≤ 3 mg/dl; AST or ALT \< 5 x ULN
* Renal: creatinine \< 1.5 x ULN
Exclusion Criteria:
* Metastases
* Prior or concomitant chemotherapy or radiation therapy
* VEGF/VEGFR- inhibitors or other anti-angiogenesis agents
* Severe and/or uncontrolled medical conditions:
* Congestive heart failure, serious cardiac arrhythmia, active coronary artery
* Severe renal impairment
* Patients who anticipate receiving major surgery during the course of the
* Pregnant or breastfeeding patients
* Evidence of bleeding diathesis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00518557
Study Brief:
Protocol Section:
NCT00518557