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 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT01171651
Eligibility Criteria:
Inclusion Criteria:
* Histological confirmation or clinical/laboratory diagnosis of primary hepatocellular carcinoma (HCC)
* Cancer is not surgically resectable for cure
* Child Pugh A or B
* Performance Score: KPS score of ≥ 70
* Platelet count ≥ 50,000 plts/mm3
* Total bilirubin ≤ 2.5 x ULN
* AST, ALT \< 5.0 x ULN
* Acceptable coagulation status: INR ≤ 1.5 x ULN
* Acceptable kidney function: Serum creatinine \< 2.0 mg/dL
* Sorafenib naive or refractory to sorafenib therapy Tumor Status: At least one intrahepatic tumor, and at least ≥50% of the total intrahepatic viable tumor mass, measurable by CT and injectable under imaging-guidance (note: injected and/or viable tumors must be previously untreated or ≥20% increase in size since preceding local-regional treatment).
Exclusion Criteria:
* Known contraindications to sorafenib
* Pregnant or nursing an infant
* Significant immunodeficiency due to underlying illness (e.g. hematological malignancies, congenital immunodeficiencies and/or HIV infection/AIDS) and/or medication (e.g. high-dose systemic corticosteroids)
* History of exfoliative skin condition (e.g. severe eczema, ectopic dermatitis, or similar skin disorder) that at some stage has required systemic therapy
* Clinically significant and/or rapidly accumulating ascites, peri-cardial and/or pleural effusions
* Severe or unstable cardiac disease
* Current, known CNS malignancy
* Use of anti-platelet or anti-coagulation medication
* Use of the following anti-viral agents: ribavirin, adefovir, cidofovir (within 7 days prior to the first treatment), and PEG-IFN (within 14 days prior to the first treatment).
* Patients with household contacts who meet any of these criteria unless alternate living arrangements can be made during the patient's active dosing period and for 7 days following the last dose of study medication:
* Pregnant or nursing an infant
* Children \< 12 months old
* History of exfoliative skin condition that at some stage has required systemic therapy
* Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01171651
Study Brief:
Protocol Section:
NCT01171651