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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT00079027
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed hepatocellular carcinoma (HCC)
* Advanced, unresectable disease
* No clinically significant ascites
* No modified Child-Pugh class C liver disease
* No main portal vein occlusion/involvement
* No extrahepatic tumor of any kind
PATIENT CHARACTERISTICS:
Age
* 18 and over (16 and over for patients residing in Scotland)
Performance status
* ECOG 0-2
Life expectancy
* More than 3 months
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Hemoglobin ≥ 8.5 g/dL
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin \< 5.0 mg/dL
* Transaminases \< 2.5 times upper limit of normal (ULN)
* INR \< 1.5
Renal
* Creatinine \< 2 times ULN
Cardiovascular
* No New York Heart Association class III or IV cardiac disease
* No acute angina
* No significant peripheral vascular disease
* No thrombosis of main portal vein
* LVEF ≥ 50%
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other concurrent serious medical condition
* No serious infection
* No psychological, familial, sociological, or geographical factors that would preclude study compliance
* No other malignancy within the past 5 years except carcinoma in situ of the cervix or non-melanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior biologic therapy for advanced unresectable HCC
Chemotherapy
* No prior systemic or regional chemotherapy
* No prior chemotherapy for advanced unresectable HCC
* No other concurrent anticancer chemotherapy
Endocrine therapy
* No prior hormonal therapy for advanced unresectable HCC
Radiotherapy
* No prior radiotherapy for advanced unresectable HCC
* No other concurrent anticancer radiotherapy
Surgery
* More than 7 days since prior major surgery
* More than 3 days since prior laparoscopy
Other
* More than 4 weeks since prior investigational agents
* More than 6 weeks since prior ablative therapy and must have radiological evidence of progression if ablated site is the only site of disease
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00079027
Study Brief:
Protocol Section:
NCT00079027