Hepatocellular Carcinoma Clinical Trial
Official title:
Phase II Study Evaluating the Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma Who Had Progressive Disease With Sorafenib
The aim of this study is to evaluate the efficacy of 5-fluorouracil + Mitomycin for the patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease with sorafenib.
Extrahepatic metastasis of hepatocellular carcinoma has recently been paradoxically
increasing due to increased survival with effective locoregional therapies. Sorafenib is the
first systemic agent that has demonstrated a significant survival benefit in patients with
advanced HCC; however, the modest improvement of 3 months is far from satisfactory. There is
no convincing evidence, to date, that systemic chemotherapy when tumor progresses after
sorafenib therapy improves overall survival. The combination of anticancer agents is
important to achieve favourable clinical results. For patients with metastatic liver cancer
or HCC, some studies have discussed the effectiveness of 5-fluorouracil/mitomycin(FM).
However, few studies have examined the actual FM regimen for HCC.
The aim of this study is to evaluate the efficacy of 5-fluorouracil/mitomycin for the
patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease
with sorafenib.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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