Anlotinib combined with SOX regimen (S1 (tegafur, gimeracil and oteracil porassium capsules) plus oxaliplatin) in treating stage IV gastric cancer: study protocol for a single-armed and single-centred clinical trial
Anlotinib combined with SOX regimen (S1 (tegafur, gimeracil and oteracil porassium capsules) plus oxaliplatin) in treating stage IV gastric cancer: study protocol for a single-armed and single-centred clinical trial
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安罗替尼联合SOX方案（S1（替加氟、吉美嘧啶、奥替拉西钾胶囊）加奥沙利铂）治疗IV期胃癌：单臂单中心临床试验研究方案
DOI：
10.1136/bmjopen-2019-034685
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发表时间：
2020-06-01
期刊：
影响因子：
2.9
通讯作者：
Ji, Gang
中科院分区：
文献类型：
--
作者：
Wang, Juan;Wu, Dong Xue;Ji, Gang
盐酸安洛替尼是一种多靶点受体酪氨酸激酶抑制剂，靶向血管生成相关激酶，在一些实体瘤中已经显示出良好的安全性和有效性。然而，安洛替尼在IV期胃癌患者的安全性和可行性的证据是稀缺的。方法和分析本研究是一个单臂和单中心的临床研究，旨在包括150例IV期胃癌患者。将收集并分析患者的人口统计学、病理学特征、用药前后血液、生化和肿瘤标志物的检测结果、无病生存期和总生存期。主要和主要疗效结局为客观缓解率、无进展生存期、疾病控制率和总生存期。次要疗效结局为安全性指标，包括药物不良反应和给药后不良事件的发生率。伦理与传播已获得第四军医大学第一附属医院（西京医院）伦理委员会批准（KY 20192111-F-1）。这项研究的结果将在几个研究会议上传播，并作为同行评审期刊上发表的文章。
Introduction Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases and has already showed good safety and efficacy in some solid tumours. However, evidence on the safety and feasibility of anlotinib in patients with stage IV gastric cancer is scarce.Methods and analysis This study is a single-armed and single-centred clinical study being designed to include 150 patients of stage IV gastric cancer. The patients' demographics, pathological characteristics, test results of blood, biochemistry and tumour markers before and after medication, disease-free survival and overall survival will be collected and analysed. The primary and main efficacy outcomes are objective response rate, progression-free survival, disease control rate and overall survival. The secondary efficacy outcome is safety indicator including the incidence of adverse drug reactions and adverse events after administration.Ethics and dissemination Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital (Xijing Hospital) of Fourth Military Medical University (KY20192111-F-1). The results of this study will be disseminated at several research conferences and as published articles in peer-reviewed journals.