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 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT00843934
Eligibility Criteria:
Inclusion Criteria:
* Subject must be histologically or clinically proven HCC, inoperable, no indication of local treatment and has measurable lesions.
* Subject must to be the first experience of TACE.
* Subject has no extra-hepatic tumor and no obstruction of main portal vein.
* Subjects must have fully recovered from previous treatment (at least 4 weeks interval is needed from prior chmotherapy or radiation therapy).
* ECOG performance status 0-2
* Child-pugh Class A or B
* Subject must have adequate functions of bonemarrow, renal, circulatory organs and appropriate examination results as below:
1. Serum Total Bilirubin 2.0mg/mL
2. WBC 3000/mm3
3. PLT 50000/mm3
4. Hb 9.0g/dL
5. Creatinine ; upper normal limit (UNL)
6. BUN 25mg/dL
* Written informed consent
Exclusion Criteria:
* Subject has extra hepatic metastasis.
* Tumor thrombosis exists at main portal vein.
* Remarkable artery-portal vein shunt or veno-arterial shunt.
* Uncontrollable ascites or pleural effusion.
* History of severe hypersensitivity.
* Any previous TACE or TAE for HCC.
* Any previous chemotherapy using epirubicin or CDDP.
* Complications as below (except chronic hepatitis or liver cirrhosis)
1. Severe heart disease
2. Myocardial infarction within 6 months
3. Renal insufficiency
4. Active infections (except virous hepatitis)
5. Gastrointestinal bleeding
6. Active double cancer
7. Hepatic encephalopathy or heavy mental disorder.
* Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant.
* Any subject judged by the investigator to be unfit for any reason to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
79 Years
Study:
NCT00843934
Study Brief:
Protocol Section:
NCT00843934