Sorafenib Plus Tegafur/Uracil (UFUR®) for Hepatocellular Carcinoma (HCC)
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
The prognosis for patients with metastatic or locally advanced hepatocellular carcinoma (HCC)
is poor. The role of conventional systemic chemotherapy has been very limited because most
chemotherapeutic agents are in-effective and relative toxic to HCC patients who tend to have
poor organ function reserves due to liver cirrhosis. The molecular-targeted therapy, which
aims at deranged signaling pathways of cancer cells or their microenvironment, holds promise
for HCC.
Sorafenib (BAY 43-9006), a novel bi-aryl urea, is a potent inhibitor of VEGFR2 and Raf
kinase. The clinical activity of sorafenib in HCC has been tested in a phase II study (Bayer
study 10874), which enrolled a total of 137 advanced HCC patients. There were 4% of
documented partial response, 5% of minor response, and 55% of stable disease. The 6- month
progression -free for the cohort was 40%. Currently, there are two on-going large-scale
randomized trials of sorafenib in advanced HCC patients worldwide.