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작성자 : admin작성일 : 2018-10-26 10:26 첨부파일 :2018) Trials- Apatinib for patients with advanced or recurrent cervical cancer.pdf

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

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.