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

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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2858-2) contains supplementary material, which is available to authorized users.