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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT01079767
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of hepatocellular carcinoma (HCC) according to the European Association for the Study of the Liver (EASL) criteria
* Advanced disease
* Must be morphologically evaluable
* HCC not accessible to other treatment (e.g., surgery, radiofrequency, or chemoembolization) and can not benefit from antiangiogenic therapy
* CLIP score ≤ 3 (except for patients with tumors invading more than 50% of tumor volume)
* Child-Pugh cirrhosis score between B7 and B9, meeting the following criteria:
* Diagnosed clinically, biologically (e.g., prothrombin time, platelets, or albumin), endoscopically (signs of portal hypertension) and morphologically (dysmorphic liver on ultrasound or CT scan), or by liver biopsy
* Not a candidate for transplantation and has not received a liver transplant
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 3 months
* Platelet count ≥ 50,000/mm\^3
* Neutrophil count ≥ 1,500/mm\^3
* Creatinine clearance ≥ 60 mL/min
* GFR ≥ 30 mL/min
* Serum cholesterol ≤ 350 mg/dL
* Triglycerides ≤ 300 mg/dL
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for more than 2 months after completion of study therapy
* No history of other cancer on treatment
* No cardiopulmonary disease impairment, including a history of stable or unstable angina or myocardial infarction
* No active infection except for viral hepatitis
* No HIV positivity
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 2 weeks since prior inhibitors or inducers of P-glycoprotein, CYP3A4, or CYP3A5
* At least 4 weeks since prior surgery, radiotherapy (except radiotherapy to the bone), transarterial chemoembolization, immunotherapy, or other investigational drug for HCC
* At least 6 months since prior chemotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01079767
Study Brief:
Protocol Section:
NCT01079767