Hepatocellular Carcinoma Clinical Trial
Official title:
Study of the Combination of Transcatheter Arterial Chemoembolization (TACE) With Apatinib in Patients With Hepatocellular Carcinoma Trial
Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver. It
is lack of effective drugs for systemic treatment of HCC. Currently, Sorafenib is the only
choice approved by FDA for advanced HCC, although it prolongs the survival for less than 3
months. The treatment of advanced HCC still has a long way to go.
At present, the relevant phase II and phase III clinical studies of apatinib on advanced HCC
are ongoing. Based on our important discovery of previous clinical studies, we intend to
enlarge the sample size and make further observation for the efficacy and safety of apatinib
in patients with advanced HCC.
Hepatocellular carcinoma (HCC) is one of the lethal human cancers worldwide and its
incidence matches mortality, reflecting the poor prognosis of this disease. The surgical
resection rate of HCC is low, and the prognosis is poor. Although transarterial
chemoembolization (TACE) is the main treatment for HCC patients who are not candidates for
surgical resection, it is not considered a curative procedure. For HCC, poor TACE efficacy
or TACE failure may be related to tumor angiogenesis of the residual disease. Among the many
regulatory factors in tumor angiogenesis, hypoxia-inducible factor-1α (HIF-1α) and vascular
endothelial growth factor (VEGF) play vital roles in this process.
Sorafenib is the first systemic treatment drug, which has been approved by the FDA for
advanced HCC. In order to find an new VEGFR-inhibitor with better effect and lower toxicity,
Jiangsu Hengrui Medicine Co., Ltd. developed Apatinib, a high-performance VEGFR-2 tyrosine
kinase inhibitor. Apatinib plays anti angiogenic effect in the treatment of malignant tumor
mainly through inhibition of VEGFR-2, in vivo and in vitro experiments showed good tumor
growth inhibitory activity on Hepatocellular carcinoma, this study aims to further verify
the efficacy and safety of Apatinib for hepatocellular carcinoma patients who are not
candidates for curative surgery, the primary endpoint is Progression Free Survival (PFS).
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