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:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
NCT ID:
NCT00524316
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically, cytologically, or serologically\* confirmed hepatocellular carcinoma meeting the following criteria:
* 1-4 lesions
* Involvement of 1 or both liver lobes NOTE: \*Alpha-fetoprotein (AFP) \> 500 mcg/L in high-risk patients
* Measurable disease by CT scan or MRI
* Disease does not exceed 50% of the liver parenchyma
* At least 1 lesion ≥ 3 cm in longest diameter
* Tumor burden involves \< 50% of the liver
* Refused surgery OR unresectable disease due to any of the following:
* Multifocality
* Advanced cirrhosis
* Comorbid illness
* Candidate for chemoembolization
* No fibrolamellar histology
* No ascites
* No known brain metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 12 weeks
* WBC ≥ 3,000/mm³
* ANC ≥ 1,500/mm³
* Hemoglobin ≥ 8.5 g/dL (transfusion allowed)
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 2 mg/dL
* AST ≤ 5 times upper limit of normal (ULN)
* INR \< 1.5
* Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 30 mL/min
* No bleeding diathesis or coagulopathy
* No active congestive heart failure
* No uncontrolled angina
* No myocardial infarction within the past 12 months
* No cardiac arrhythmia
* Ejection fraction ≥ 45% (in patients with known coronary artery disease and in patients \> 50 years of age)
* Child-Pugh class A or B cirrhosis
* No impedance of hepatopedal blood flow (portal vein thrombosis)
* No thrombosis of the main portal vein
* No encephalopathy
* No biliary obstruction
* No variceal bleed within the past 6 months
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate
* No absolute contraindication to doxorubicin, iodinated contrast material, microfibrillar collage hemostat, or dexamethasone
* No other concurrent uncontrolled illness including, but not limited to, any of the following:
* Ongoing or active infection
* Psychiatric illness or social situation that would limit compliance with study requirements
* No other active malignancies within the past year except nonmelanoma skin cancer or carcinoma in situ
* No significant traumatic injury within the past 4 weeks
* No QTc prolongation (i.e., QTc interval ≥ 500 msec) or other significant ECG abnormalities
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after the completion of study treatment
PRIOR CONCURRENT THERAPY:
* Recovered from prior therapy
* Prior liver-directed therapy, such as chemoembolization, radiofrequency ablation, cryoablation, or ethanol injection allowed if the following criteria are met:
* Treated lesion remains inactive by CT scan or MRI and new lesion being embolized is distinct from the previously treated lesion
* Radiographic progression of previously treated lesion requiring re-embolization
* Prior liver resection allowed
* Prior immunotherapy allowed
* No prior antiangiogenesis therapy
* No prior liver transplantation
* Patients awaiting a cadaveric or orthotopic liver transplantation are eligible provided they have end-stage liver disease with a priority score of \< 20 points
* More than 4 weeks since prior radiotherapy or chemotherapy (6 weeks for nitrosoureas or mitomycin C)
* More than 4 weeks since prior major surgery or open biopsy
* At least 1 week since prior fine needle biopsy
* No concurrent immunotherapy
* No concurrent radiotherapy
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No concurrent therapeutic doses of coumarin-derivative anticoagulants (e.g., warfarin)
* Doses of ≤ 1 mg/day are allowed for prophylaxis of thrombosis as long as INR ≤ 1.5
* Both full dose and prophylactic dose low molecular weight heparin allowed as long as PT INR ≤ 1.5
* No anticipated major surgery during and for 3 months after completion of study treatment
* No other concurrent investigational agents
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00524316
Study Brief:
Protocol Section:
NCT00524316