Background: Kanglaite injection is a broad-spectrum anti-tumor drug, which is extracted from the seeds of the Chinese medicinal herb Coix lacryma-jobi, and has been widely used for the treatment of gastric cancer (GC). This study aimed to systematically investigate the efficacy and safety of Kanglaite injection for the treatment of GC.

Methods: We will perform the comprehensive literature search in English and Chinese electronic database from its inception to June 2020. Two trained researchers will independently select the qualified studies for data extraction and assess the quality and risk of bias. Cochrane Risk of Bias tool will be used to assess the risk of bias of included studies. The outcomes included overall response rate, complete response rate, 3-year progression-free survival rate, 3-year overall survival rate, and different types of treatment-related adverse events. Funnel plot analysis and Egger test will be used to assess the publication bias. Finally, the quality of evidence will be assessed by the grading of recommendations assessment, development, and evaluate system . We will calculate the risk ratio as well as their 95% confidence intervals of these outcomes and pool the results using RevMan 5.4 software and STATA 16.0 software.

Results: The results of our research will be published in a peer-reviewed journal.

Conclusion: The conclusion of our systematic review will provide evidence to judge whether Kanglaite injection is an effective intervention for patient with GC.

Osf registration number: 10.17605/OSF.IO/HF679.