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 @ 4:56 PM
Ignite Modification Date:
2025-12-24 @ 4:56 PM
NCT ID:
NCT01032850
Eligibility Criteria:
Inclusion Criteria:
Histologic diagnosis of hepatocellular carcinoma The lesion or lesions are not resectable with curative intent. Prior loco-regional treatment (resection, RFA, chemoembolization) is allowed.
Adequate bone marrow function:
* Absolute neutrophil count (AGC) \>1500/µL
* Platelet count \>60,000 /µL
Renal function:
* Serum creatinine \< 2.0 mg/dl, and a calculated CCT of \> 30 mL/min. Hepatic function:(Patients with a Child-Pugh (C-P) class A-B)
* Bilirubin \< 2.8 mg/dl (provided the Child-Pugh class of liver cirrhosis is A or B (7) (ie. The Child-Pugh score is only 7 points)
* ALT and AST ≤ 5.0 times the ULN • Hemoglobin \> 8.5 g/dl
ECOG/Zubrod/SWOG Performance Status = 0\>1 Life expectancy \> 16 weeks Male or female' age \>18 years Patients of childbearing potential must be using an effective means of contraception.
INR \< 1.5 or a PT/PTT within normal limits.
Exclusion Criteria:
* Any prior systemic therapy including chemotherapy of targeted agents
* Uncontrolled ascites defined as not easily controlled by stable doses of diuretics.
* Pregnant or lactating females
* Cardiac disease: Congestive heart failure \> class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
* Uncontrolled' clinically significant dysrhythmia
* History of prior malignancy within the prior 3 years, with the exception of non-melanoma carcinomas of the skin, carcinoma in situ of the cervix or breast, Rai Stage I chronic lymphocytic leukemia and superficial bladder cancer.
* Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion
* Uncontrolled metastatic disease of the central nervous system
* Radiotherapy within the 2 weeks before Cycle 1' Day 1
* Surgery within the 2 weeks before Cycle 1' Day 1
* Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications.
* Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
* Known human immunodeficiency virus (HIV) infection.
* Patients with chronic Hepatitis B or C infections are eligible.
* Active clinically serious infection \> CTCAE Grade 2.
* Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
* Pulmonary hemorrhage/bleeding event \> CTCAE Grade 2 within 4 weeks of first dose of study drug.
* Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug.
* Serious non-healing wound, ulcer, or bone fracture.
* Evidence or history of bleeding diathesis or coagulopathy.
* Use of St. John's Wort or rifampin (rifampicin).
* Known or suspected allergy to sorafenib or any agent given in the course of this trial.
* Any condition that impairs patient's ability to swallow whole pills.
* Any malabsorption problem.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01032850
Study Brief:
Protocol Section:
NCT01032850