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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT00881751
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Pathologically confirmed advanced hepatocellular carcinoma (HCC)
* Childs-Pugh class A
* CLIP score ≤ 5
* Not a candidate for curative surgical resection or loco-regional therapy
* Measurable disease as per RECIST 1.1 criteria, defined as ≥ 1 previously unirradiated, bidimensionally measurable lesion ≥ 20 mm by CT scan or MRI (triphasic spiral CT scan or MRI employing a "liver protocol" image capture technique required)
* Bone lesions, ascites, and pleural effusions are not considered measurable lesions
* No fibrolamellar HCC
* No known brain metastases
* No prior organ transplantation
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 75,000/mm³
* Hemoglobin ≥ 9 g/dL
* Transaminases ≤ 5 times upper limit of normal (ULN)
* Total bilirubin ≤ 2.0 times ULN
* PT ≤ 1.8 times ULN
* Prolonged INR allowed for patients who require full dose anticoagulation
* Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 45 mL/min
* Urine protein \< 2+ by urine dipstick OR urine protein ≤ 1 g by 24-hour urine collection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 12 weeks after completion of study treatment
* Able to take and absorb oral medication
* No active infection requiring parenteral therapy
* No known HIV or AIDS
* No uncontrolled blood pressure (BP), defined as systolic BP ≥ 150 mm Hg and/or diastolic BP ≥ 100 mm Hg
* No uncontrolled or significant cardiovascular disease, including any of the following:
* Myocardial infarction within the past 6 months
* Uncontrolled angina within the past 6 months
* New York Heart Association class II-IV congestive heart failure
* Grade 3 cardiac valve dysfunction
* Cardiac arrhythmia not controlled by medication
* Stroke or transient ischemic attack within the past 6 months
* Arterial thrombotic event of any type within the past 6 months
* No significant or symptomatic vascular disease (e.g., aortic aneurysm, aortic dissection, or peripheral vascular disease) within the past 6 months
* No decompensated liver disease as evidenced by clinically significant ascites refractory to diuretic therapy, hepatic encephalopathy, or coagulopathy not corrected by conservative measures
* No grade 3 bleeding esophageal or gastric varices within the past 2 months
* Prior variceal bleeding allowed provided patient has undergone banding or sclerotherapy and there has been no evidence of bleeding for 2 months
* No gastric varices ≥ grade 2
* No hemoptysis (i.e., ≥ ½ teaspoon of bright red blood per episode) within the past month
* No evidence of bleeding diathesis or coagulopathy
* No concurrent uncontrolled illness, including, but not limited to, a history of or current evidence of unexplained nephrotic syndrome or other severe illness/disease that would preclude study participation
* No history of hypertensive crisis or hypertensive encephalopathy
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
* No serious, non-healing wound, active ulcer, or untreated bone fracture
* No significant traumatic injury within the past 28 days
* No history of allergy to bevacizumab, erlotinib hydrochloride, sorafenib tosylate, or related compounds
* No other primary malignancy within the past 5 years, except carcinoma in situ of the cervix or urinary bladder or nonmelanoma skin cancer
* No mental incapacitation or psychiatric illness that would preclude study participation
* Not incarcerated or compulsorily detained (i.e., involuntarily incarcerated) for treatment of either a psychiatric or physical illness (e.g., infectious disease)
PRIOR CONCURRENT THERAPY:
* Prior surgery, local ablation, trans-arterial hepatic artery embolization, or trans-arterial chemoembolization are allowed provided the lesion(s) have progressed since treatment OR there are additional measurable, untreated lesions present
* No prior systemic therapy for HCC
* No prior organ transplantation
* More than 7 days since prior minor surgical procedures, fine needle aspirations, or core biopsies (excluding placement of a vascular access device)
* More than 28 days since any prior therapy
* More than 28 days since prior and no concurrent major surgical procedure or open biopsy
* More than 28 days since prior and no concurrent participation in another experimental drug study
* No other concurrent anticancer or antitumor therapy, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy
* No other concurrent investigational agents
* No concurrent warfarin (other types of anticoagulation allowed)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
116 Years
Study:
NCT00881751
Study Brief:
Protocol Section:
NCT00881751