Department of Gastrointestinal Surgery, Sichuan University West China Hospital, Chengdu, China.
Evidence-Based Pharmacy Center, Sichuan University West China Second University Hospital, Chengdu, China.
BMJ Open. 2021 Dec 24;11(12):e049575. doi: 10.1136/bmjopen-2021-049575.
Phase I/II clinical trials suggested that the hepatocyte growth factor (HGF)/mesenchymal-epithelial transition (MET) pathway-targeted agents were active in suppression of gastric cancer (GC). Randomised controlled trials (RCTs) were undertaken assessing whether the addition of anti-HGF/MET agent (rilotumumab or onartuzumab) to chemotherapy improves survival outcomes of advanced GC, but conflict conclusions were reached. Therefore, we plan to perform this systematic review and meta-analysis to synthesise evidence concerning efficacy and safety of anti-HGF/MET agents combined with chemotherapy as the first-line treatment to advanced GC.
Systematic searches of the PubMed, Embase and the Cochrane Central Register of Controlled Trials will be performed with no language restriction from inception to 31 January 2022 to identify RCTs exploring the comparative efficacy and safety of anti-HGF/MET agents plus chemotherapy as first-line treatment in advanced GC. The primary outcome will be the time-to-event progression-free survival and overall survival, and the secondary outcomes will be disease control rate, overall adverse events rate and grade 3-5 adverse events rate. Statistical heterogeneity will be assessed by visual inspection of forest plots and measured using the I statistics. A fixed-effect model will be used when heterogeneity is low otherwise, a random-effect model will be chosen. Publication bias will be assessed by funnel plots; subgroup analysis and sensitivity analysis will be performed in the right context. For each outcome, we will perform data synthesis using Rev Man V.5.3 software, and compile 'summary of findings' tables using GRADEpro software.
There is no requirement for ethics approval because no individual data will be collected in this research. It is anticipated that the dissemination of results will take place at conferences and through publication in a peer-review journal, any adjustments from the protocol will be clearly documented and explained in its final report.
CRD42020177404.
I/II 期临床试验表明，肝细胞生长因子（HGF）/间质上皮转化（MET）通路靶向药物在抑制胃癌（GC）方面具有活性。已经进行了随机对照试验（RCT），以评估抗 HGF/MET 药物（rilotumumab 或 onartuzumab）联合化疗是否能改善晚期 GC 的生存结局，但得出的结论相互矛盾。因此，我们计划进行这项系统评价和荟萃分析，以综合评估抗 HGF/MET 药物联合化疗作为晚期 GC 一线治疗的疗效和安全性证据。
从成立到 2022 年 1 月 31 日，我们将对 PubMed、Embase 和 Cochrane 对照试验中心注册库进行系统检索，不限制语言，以确定探索抗 HGF/MET 药物联合化疗作为晚期 GC 一线治疗的比较疗效和安全性的 RCT。主要结局将是无进展生存时间和总生存时间，次要结局将是疾病控制率、总不良事件发生率和 3-5 级不良事件发生率。通过森林图的直观检查和 I ² 统计来评估统计异质性。当异质性低时，将使用固定效应模型；否则，将选择随机效应模型。通过漏斗图评估发表偏倚；在适当的情况下进行亚组分析和敏感性分析。对于每个结局，我们将使用 Rev Man V.5.3 软件进行数据合成，并使用 GRADEpro 软件编制“发现总结”表。
由于本研究不收集个体数据，因此不需要伦理批准。预计结果将在会议上公布，并在同行评议期刊上发表，对方案的任何调整都将在最终报告中明确记录和解释。
PROSPERO 注册号：CRD42020177404。
