Chemotherapy combined with immunotherapy in patients with gastric cancer: protocol for a systematic review

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.