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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT01164202
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed hepatocellular carcinoma or liver tumor responding to the Barcelona criteria
* Child-Pugh score of 5-6 (Class A)
* Tumor suitable for transarterial chemoembolization (one or more planned courses allowed)
* Tumor not suitable for surgical resection
* No extrahepatic metastases, including cerebral metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1.5 x 10\^9/L
* Platelet count ≥ 100 x 10\^9/L
* Hemoglobin ≥ 10 g/dL
* PT ≥ 50%
* Creatinine ≤ 120 μmol/L
* Bilirubin normal
* ALT/AST ≤ 3.5 times upper limit of normal (ULN)
* Alkaline phosphatases ≤ 4 times ULN
* Fibrinogen ≥ 1.5 g/L
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No portal vein thrombosis
* Able to comply with scheduled follow-up and management of toxicity
* No uncontrolled hypertension or requiring ≥ 2 classes of antihypertensive drugs
* No concomitant disease or uncontrolled severe disease
* No contraindications to the vascular occlusion procedure
* No prior or concurrent malignancy within the past 5 years, except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell carcinoma of the skin
* No psychiatric disability or social, family, or geographic reason for which the patient may not be followed regularly
PRIOR CONCURRENT THERAPY:
* At least 7 days since prior CYP3A4 inhibitors or inducers
* At least 3 months since prior radiofrequency ablation
* No prior chemotherapy
* No prior sunitinib, sorafenib, or any other inhibitors of angiogenesis
* No concurrent participation in another trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT01164202
Study Brief:
Protocol Section:
NCT01164202