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 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT00055692
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed hepatocellular carcinoma
* Confirmed by needle aspirate, biopsy, or prior surgical resection specimen
* Clinically confirmed hepatocellular carcinoma defined as follows:
* Cirrhosis or chronic hepatitis B or C virus infection, with 1 or more hypervascular liver masses more than 2 cm
* Alpha-fetoprotein (AFP) greater than 400 ng/mL OR greater than 3 times normal and doubling in value during the past 3 months
* Deemed unresectable
* Prior surgical resection allowed
* Recurrence after hepatic resection or other procedure allowed
* Tumor that extends into branches of the portal or hepatic veins allowed
* No tumor invading the main portal vein (portal trunk) or inferior vena cava
* No tumor occupying more than 50% of the liver volume
* Enlargement/involvement of regional lymph nodes allowed
* At least 1 unidimensionally measurable lesion at least 20 mm
* No poorly defined lesions
* No vague hypervascular patches
* Child-Pugh class A or compensated Child-Pugh class B liver dysfunction
* No Child-Pugh class C or uncompensated class B indicated by active encephalopathy, persistent ascites, or prothrombin time greater than 1.5 times normal
* Prior ascites allowed if manageable with diuretics alone
* No repeated paracentesis (more than 1 per month)
* No extrahepatic metastasis
* No documented brain metastases
* No history or clinical evidence of CNS disease (e.g., primary brain tumor, seizures uncontrolled with standard medical therapy, or history of stroke)
* Performance status - ECOG 0-2
* Absolute neutrophil count greater than 1,500/mm\^3
* Hemoglobin at least 8 g/dL
* Platelet count at least 75,000/mm\^3
* No prior serious bleeding event (unrelated to liver disease)
* No bleeding diathesis
* No coagulopathy
* Bilirubin no greater than 3 mg/dL
* Transaminases less than 5 times upper limit of normal (ULN)
* Albumin at least 2.5 mg/dL
* PTT less than 4 seconds above ULN
* INR less than 1.5 (for patients receiving warfarin)
* Creatinine less than 1.5 g/dL
* Urine protein less than 500 mg/24hrs\*
Exclusion criteria:
* No thromboembolic event within the past 12 months
* No clinically significant cardiovascular disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection requiring parenteral antibiotics
* No serious non-healing wound/ulcer or bone fracture
* No variceal bleeding within the past 6 months
* No malignancy within the past 5 years except localized nonmelanoma skin cancer
* No ongoing psychiatric or social situation that would preclude study compliance
* No known hypersensitivity to Chinese hamster ovary cell products
* No known hypersensitivity to other recombinant human antibodies
* No more than 1 prior biologic therapy
* No concurrent interferon
* No concurrent interleukin-2
* No more than 1 prior antineoplastic chemotherapy
* At least 4 weeks since prior invasive surgery, including open biopsy
* At least 2 weeks since prior needle biopsy (core or fine-needle aspirate)
* No concurrent hepatic transplant
* At least 4 weeks since prior anticancer therapy
* No concurrent platelet-stimulating factors (e.g., oprelvekin)
* No concurrent full-dose anticoagulants or thrombolytic agents (except as required to maintain patency of pre-existing, permanent indwelling IV catheters)
* No chronic daily antiplatelet drugs (e.g., aspirin doses of 325 mg/day or higher or non-steroidal anti-inflammatory drugs)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00055692
Study Brief:
Protocol Section:
NCT00055692