Tong Hongxuan, Hao Yu, Wang Kaili, Xiang Lekang, Lu Tao
Chinese Medicine, Beijing, China School of Life Sciences, Beijing University of Chinese Medicine.
Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
Medicine (Baltimore). 2020 Mar;99(11):e19367. doi: 10.1097/MD.0000000000019367.
This systematic review protocol aims to provide the methods used to assess the total benefits and side effects in all cancer patients and their respective benefits and side effects in different cancers.
The following electronic bibliographic databases will be selected without any language restriction: PubMed, EMBASE, The Cochrane Library, Scopus and Web of Science without an upper-limit date until July 12, 2019. Searches will also be performed in the following trials registers: ClinicalTrials.gov (www.ClinicalTrials.gov), the ISRCTN registry (www.isrctn.com), the WHO International Clinical Trials Registry Platform (www.who.int/trialsearch/Default.aspx) and the EU Clinical Trials Register (www.clinicaltrialsregister.eu). All randomized controlled trials related to the combination of nivolumab and ipilimumab for cancer patients will be included. Outcomes will include curative effect, chemotherapeutic response rate, adverse events. Study inclusion, data extraction and quality assessment will be performed independently by two reviewers. Assessment of risk of bias and data synthesis will be performed using Review Manager software.
Ethics approval is not required because individual patients' data are not included. The findings of this systematic review will be disseminated through peer-reviewed publication.
CRD42018109732.
本系统评价方案旨在提供用于评估所有癌症患者的总体获益和副作用以及不同癌症各自的获益和副作用的方法。
将选择以下无任何语言限制的电子文献数据库:PubMed、EMBASE、Cochrane图书馆、Scopus和Web of Science,检索截止日期为2019年7月12日,无上限日期。还将在以下试验注册库中进行检索:ClinicalTrials.gov(www.ClinicalTrials.gov)、ISRCTN注册库(www.isrctn.com)、世界卫生组织国际临床试验注册平台(www.who.int/trialsearch/Default.aspx)和欧盟临床试验注册库(www.clinicaltrialsregister.eu)。将纳入所有与纳武单抗和伊匹单抗联合用于癌症患者相关的随机对照试验。结局将包括疗效、化疗反应率、不良事件。研究纳入、数据提取和质量评估将由两名研究者独立进行。将使用Review Manager软件进行偏倚风险评估和数据合成。
由于不包括个体患者数据,因此无需伦理批准。本系统评价的结果将通过同行评审发表进行传播。
PROSPERO注册号:CRD42018109732。