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Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Apatinib for patients with advanced or recurrent cervical cancer: study protocol for an open-label randomized controlled trial

Authors: Jian-Guo Zhou, Nan-Jing Zhou, Qiong Zhang, Yao-yao Feng, Hang Zhou

Published in: Trials | Issue 1/2018

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Abstract

Background

In China, cervical cancer is the fifth most commonly diagnosed cancer, and the outcomes for patients with advanced or recurrent disease are poor. Apatinib, a small molecule inhibitor of vascular endothelial growth factor receptor (VEGFR-2), is an orally bioavailable agent, which has shown survival benefit in multiple solid tumors. Based on previous research, this phase II clinical trial aims to verify apatinib’s efficacy and safety in patients with advanced or recurrent cervical cancer.

Methods/design

This randomized, parallel arm, open-label, interventional trial will be carried out to evaluate the efficacy and the safety of apatinib for advanced or recurrent cervical cancer. A total of 60 eligible patients will be allocated by intention, in a ratio of 1:1, to either the experimental group or the control group. The primary endpoint is progression-free survival, the secondary endpoints include overall survival, disease control rate, objective response rate, quality of life, and adverse events. Assessments will be carried out before enrolment (baseline) and every 4 weeks after treatment.

Discussion

The aim of this trial is to demonstrate the clinical effect, safety, and side effects of apatinib in the treatment of advanced or recurrent cervical cancer. This study will clarify the efficacy and safety of this regimen.

Trial registration

Chinese Clinical Trials Registry, ChiCTR-OIN-17012164. Registered on 24 July 2017.
Appendix
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Metadata
Title
Apatinib for patients with advanced or recurrent cervical cancer: study protocol for an open-label randomized controlled trial
Authors
Jian-Guo Zhou
Nan-Jing Zhou
Qiong Zhang
Yao-yao Feng
Hang Zhou
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2858-2

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