NCT02772029

A Study of Apatinib for Advanced Hepatocellular Carcinoma Patients After First-line Treatment Failure

A Pilot Study of Apatinib for Advanced Hepatocellular Carcinoma Patients After First-line Treatment Failure

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Apatinib Mesylate Tablets	Apatinib 750 mg is administered orally daily, until disease progression or untolerable toxicity.

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2016-05-13
• Last updated: 2016-05-13