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 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT00390195
Eligibility Criteria:
Inclusion Criteria:
* Patients with measurable, metastatic or locally advanced HCC that are not feasible to have or have failed to prior local therapy (including surgical resection, transarterial chemoembolization and/or alcohol injection) are eligible.
* The diagnosis of HCC should be established either by cyto/histology; or, by characteristic imaging studies (have to including angiography) plus serum level of AFP equal to or more than 400 ng/mL in patients with cirrhosis of the liver and/or chronic viral hepatitis B or C infection.
* Patients must be equal to or more than 20 years of age and equal or less than 75 years of age.
* Patients must have a performance status of ECOG score equal to or less than 2.
* Patients must fulfill all of the following criteria: Child-Pugh's Score equal to or less than 9; serum total bilirubin level is equal to or less than 2.0 mg/dL; serum ALT level (GPT) equal to or less than 3.0 x upper normal limit; platelet are equal to or more than 50,000 / uL; WBC are equal to or more than 3,000 / uL.
* Serum creatinine equal to or less than 2.0 x upper normal limit.
* Life expectancy equal to or more than 12 weeks.
* Signed informed consent.
* Sexually active patients, in conjunction with their partner, must practice birth control during, and for 2 months after therapy.
* Female patients at child-bearing age must have negative pregnancy test.
* No known HIV infection.
Exclusion Criteria:
* Patients with diseases which require concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
* Patients with concomitant active secondary malignancies, except for surgically cured carcinoma in situ of the cervix and basal or adequately treated squamous cell carcinoma of the skin, or disease-free of malignancies \< 3 years before the study, are not eligible.
* Patients with active infection are not eligible.
* Patients who received other rapamycin analogs before are not eligible.
* Patients with severe cardiopulmonary diseases (including history of stable, effort-induced or unstable angina pectoris or myocardiac infarction) and other systemic diseases under poor control are not eligible.
* Patients with history of psychiatric disorder are not eligible.
* Patients with brain metastases are not eligible.
* Patients who received surgery, radiotherapy except to bone, chemotherapy, immunotherapy, or other investigational drug within 4 weeks before initiating study are not eligible.
* Patients who are pregnant, breast-feeding or not using appropriate birth control during the course of the study are not eligible.
* Patients with significant concomitant disease that will be aggravated by the investigational drug are not eligible.
* Patients on active treatment with inhibitors or inducers of P-glycoprotein, CYP3A4 and CYP3A5 are not eligible; a minimal of 2 weeks wash-out period will be required after stop such medications.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT00390195
Study Brief:
Protocol Section:
NCT00390195