Phase II Study Evaluating the Efficacy of Bevacizumab (Avastin@) in Hepatocellular Carcinoma Not Amenable to Curative Treatment
- Histologically or cytologically proven HCC or alpha-fetoprotein level > 400 ng/ml
together with hypervascular tumor and cirrhosis documented by CT scan or MRI.
- HCC not amenable to curative treatment (resection, transplantation, percutaneous
- Presence of at least one dimensionally measurable target lesion with largest diameter
>= 2 cm.
- No previous chemoembolization, no previous radiotherapy
- Cancer of the Liver Italian Program (CLIP) score < 4
- World Health Organization (WHO) performance status of 2 or less
- Life expectancy >= 3 months.
- Age >= 18 years.
- Adequate hematologic functions (neutrophil count, at least 1500 per cubic millimeter;
platelet count, at least 75,000 per cubic millimetre; Hemoglobin, at least 8 g/dl)
- Adequate liver function (bilirubin, not more than 2 times the upper limit of normal);
Adequate renal function (serum creatinine, less than 150 micromol per liter)
- Adequate coagulation function
- Written informed consent
- Decompensated cirrhosis (Child-Pugh score > 7)
- CLIP score > 4
- Variceal bleeding during the previous 3 months
- Thromboembolic event during the previous 6 months
- Medical condition requiring full dose anticoagulation or anti-platelet drugs
- Abnormal cardiac function with history of ischemic heart disease in the previous 6
months, uncontrolled hypertension, unstable angina, severe cardiac arrhythmia,
- No brain metastasis, No bone metastasis only
- Previous or current malignancies at other sites
- No concomitant antitumor treatment including tamoxifen or somatostatin analogs
- Unstable systemic diseases or active uncontrolled infections.
- Patients (male and female) not using effective contraception if of reproductive