A Study of Apatinib for Advanced Hepatocellular Carcinoma Patients After First-line Treatment Failure
Status:
Unknown status
Trial end date:
2017-09-01
Target enrollment:
Participant gender:
Summary
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 glioma, this study aims to further verify the efficacy and
safety of Apatinib for first-line treatment failure hepatocellular carcinoma patients, the
primary endpoint is time to progression(TTP).
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou University