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The Clinical Study of Apatinib Plus S1 for Patients With Advanced Non-squamous Head and Neck Cancer

Head and Neck Neoplasms Clinical Trial

Official title:
PhaseⅡSingle-center, Open-label, Exploratory Clinical Study of Apatinib in Combination With S1 for the Patients With Advanced Non-squamous Head and Neck Cancer

Clinical Trial Summary

This is a Single-center, Open-label, Single-arm, Phase Ⅱ exploratory clinical trial evaluating the efficacy and safety of Apatinib plus S1 for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer.

Clinical Trial Description

There is no standard therapy for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer. Apatinib is a novel vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor, which has been approved for the treatment of patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. Vascular endothelial growth factor is highly expressed in non-squamous head and neck cancer and its expression correlates with stage, tumour size, vascular invasion, recurrence and metastasis. S1 is a new kind of oral fluorouracil antineoplastic chemotherapy drugs. In vitro, apatinib has synergy effect with fluorouracil. In this study, the investigators try to evaluate the efficacy and safety of apatinib and S1 in advanced non-squamous head and neck cancer and to validate the correlative biomarkers. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02943252
Study type Interventional
Source Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact Xiaohui He, B.D.
Phone +86-13810670129
Email xiaohuih2008@163.com
Status Recruiting
Phase Phase 2
Start date October 2016
Completion date October 2021
View Details
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