Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

1-The patient must provide written informed consent prior to enrollment into the study.

2-The patient must be at least 18 years of age. 3-Patients must have histologically or cytologically confirmed or radiologically confirmed (according to AASLD criteria) advanced (unresectable, and/or metastatic) HCC not eligible for local ablation or TACE.

4-Patients must have measurable disease according to RECIST criteria (at least one uni-dimensional lesion measurable by CT-scan or MRI) 5-Patients must have a life expectancy of at least 12 weeks 6-Patients must have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 -2, Child-Pugh class A and only B7 7-Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

Hemoglobin ≥ 9.0 g/dl
Absolute neutrophil count (ANC) ≥ 1,500/mm3
Platelet count ≥ 100,000/μl
Total bilirubin ≤ 1.5 times the upper limit of normal
ALT and AST < 5 x upper limit of normal
Alkaline phosphatase ≤ 5 x upper limit of normal
PT-INR/PTT < 1.5 x upper limit of normal
Serum creatinine < 1.5 x upper limit

Amylase and lipase < 1.5 X the upper limit of normal 8-For patients, who have had major surgery or injury, the wound must be completely healed prior to receiving sorafenib treatment (4 weeks).

9-Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Men use adequate birth control for at least 3 months after the last administration of sorafenib

Exclusion Criteria:

Excluded medical conditions:

History of cardiac disease: congestive heart failure > NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
History of HIV infection
Patients with Child-Pugh class C hepatic impairment
Patients with Child-Pugh class B (except 7 ) hepatic impairment
Active clinically serious infections (grade 2 NCI-CTC version 3.0)
Symptomatic metastatic brain or meningeal tumors
Patients with seizure disorder requiring medication (such as steroids or antiepileptics)
History of organ allograft
Patients with evidence or history of bleeding due to OV
Patients undergoing renal dialysis
Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma

Patients not fulfilling inclusion criteria.

Excluded therapies and medications, previous and concomitant:

Prior systemic anticancer chemotherapy or immunotherapy or targeted therapy is not allowed before study entry.
Hormonal therapy shouldn't be given within 2 weeks before study entry and is not allowed during the study.
Patients who failed previous transcatheter arterial chemoembolism must have at least 4 weeks treatment free interval before entering the study
Radiotherapy during study or within 3 weeks of start of study drug.
Major surgery within 4 weeks of start of study
Investigational drug therapy outside of this trial during or within 4 weeks of study entry
Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Known or suspected allergy to the investigational agent or any agent given in association with this trial
Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study