This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Treatment options for unresectable and advanced hepatocellular carcinoma (HCC) are extremely limited. Evidence from laboratory studies and human tissue suggest that angiogenesis is vital to the progression of HCC and that VEGF activity contributes significantly to this process. This study will evaluate the effect of VEGF inhibition (via bevacizumab) in patients with unresectable and advanced HCC. Bevacizumab (formerly known as rhuMab-VEGF, commercial name Avastin) is a recombinant humanized version of a murine anti-human VEGF monoclonal antibody. The overall design is a phase II study of bevacizumab, given every 14 days, at a dose of 10 mg/kg. Because this drug has not been extensively tested in patients with liver cirrhosis, additional safety precautions have been added. An initial cohort of patients will be treated at a reduced (5 mg/kg) dose, with dose escalation to 10 mg/kg if well tolerated. The study will determine, the effect on progression-free survival, disease stability and response, tumor vascularity and necrosis, circulating VEGF and related cytokines believed to be pathogenic in HCC. The effect of VEGF inhibition on liver function and hepatitis viral activity in cirrhosis will also be evaluated.
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