Han Yihui, Yang Wenming, Meng Yang, Cai Zhaolun, Zhang Bo
Department of General Surgery, West China Hospital of Sichuan University, Chengdu, Sichuan, China.
Gastric Cancer Center, West China Hospital of Sichuan University, Chengdu, Sichuan, China.
BMJ Open. 2024 Dec 15;14(12):e086986. doi: 10.1136/bmjopen-2024-086986.
The integration of chemotherapy and immunotherapy is continually making new advances in the field of gastric cancer treatment and has already become the new standard of care for the disease. However, few systematic reviews cover a wide array of immune checkpoint inhibitors (ICIs), antibody types and therapeutic modalities (perioperative or systemic) in this domain. Our aim is to incorporate the most recent clinical studies on combination therapy for the treatment of gastric cancer into a systematic review. This will comprehensively assess the benefits and drawbacks for patients with gastric cancer and will guide future research in this area. Ultimately, this will provide evidence-based support for patients with gastric cancer.
This protocol for a systematic review adheres to the Preferred Reporting Items for Systematic Review and Meta-analysis - Protocols (PRISMA-P) guidelines. We will conduct a search of the MEDLINE, Embase, and CENTRAL databases from database inception, all retrieved literature will be screened by two authors in two rounds. Inclusion criteria will be randomised clinical trials, reported in English, that compare immunotherapy-combined therapy with chemotherapy alone in the perioperative and systematic first-line treatment of gastric cancer. The primary outcomes will be progression-free survival (PFS) and overall survival (OS). Secondary outcomes will include objective response rate (ORR), event-free survival (EFS), disease-free survival (DFS), pathologic complete response (pCR), major pathologic response (MPR), and the R0 resection rate. Heterogeneity and publication bias of included literature will be investigated. Where included literatures allow, we will conduct meta-analyses and subgroup analyses to further refine the pros and cons of combined therapy, providing evidence-based foundations for subsequent research.
This work is a review based on existing literature and no ethical review is required. Dissemination of the results will occur via academic journal publication, conference presentations, and multiple media platforms.
CRD42023477353.
化疗与免疫疗法的联合应用在胃癌治疗领域不断取得新进展，已成为该疾病的新治疗标准。然而，很少有系统评价涵盖该领域广泛的免疫检查点抑制剂（ICI）、抗体类型和治疗方式（围手术期或全身治疗）。我们的目的是将关于胃癌联合治疗的最新临床研究纳入系统评价。这将全面评估胃癌患者的利弊，并指导该领域的未来研究。最终，这将为胃癌患者提供循证支持。
本系统评价方案遵循系统评价与Meta分析方案的首选报告项目（PRISMA-P）指南。我们将从数据库建立起对MEDLINE、Embase和CENTRAL数据库进行检索，所有检索到的文献将由两位作者分两轮进行筛选。纳入标准将是随机临床试验，以英文报道，比较免疫疗法联合治疗与单纯化疗在胃癌围手术期和一线全身治疗中的效果。主要结局将是无进展生存期（PFS）和总生存期（OS）。次要结局将包括客观缓解率（ORR）、无事件生存期（EFS）、无病生存期（DFS）、病理完全缓解（pCR）、主要病理缓解（MPR）和R0切除率。将调查纳入文献的异质性和发表偏倚。在纳入文献允许的情况下，我们将进行Meta分析和亚组分析，以进一步明确联合治疗的利弊，为后续研究提供循证基础。
本研究是基于现有文献的综述，无需伦理审查。研究结果将通过学术期刊发表、会议报告和多个媒体平台进行传播。
PROSPERO注册号：CRD42023477353。
