Zhou Jian-Guo, Zhou Nan-Jing, Zhang Qiong, Feng Yao-Yao, Zhou Hang
Department of Oncology, Affiliated Hospital of Zunyi Medical University, NO.149, Dalian Road, Zunyi, 563000, China.
Trials. 2018 Sep 17;19(1):500. doi: 10.1186/s13063-018-2858-2.
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.
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.
Chinese Clinical Trials Registry, ChiCTR-OIN-17012164 . Registered on 24 July 2017.
在中国，宫颈癌是第五大常见诊断癌症，晚期或复发性疾病患者的预后较差。阿帕替尼是一种血管内皮生长因子受体（VEGFR - 2）小分子抑制剂，是一种口服生物利用度良好的药物，已在多种实体瘤中显示出生存获益。基于先前的研究，这项II期临床试验旨在验证阿帕替尼在晚期或复发性宫颈癌患者中的疗效和安全性。
方法/设计：本随机、平行组、开放标签的干预性试验将评估阿帕替尼治疗晚期或复发性宫颈癌的疗效和安全性。总共60名符合条件的患者将按意向性以1:1的比例分配到试验组或对照组。主要终点是无进展生存期，次要终点包括总生存期、疾病控制率、客观缓解率、生活质量和不良事件。评估将在入组前（基线）和治疗后每4周进行一次。
本试验的目的是证明阿帕替尼治疗晚期或复发性宫颈癌的临床疗效、安全性和副作用。本研究将阐明该治疗方案的疗效和安全性。
中国临床试验注册中心，ChiCTR - OIN - 17012164。于2017年7月24日注册。
