Efficacy and safety of TCM therapies combined with hyperthermic intraperitoneal chemotherapy for peritoneal metastasis of gastric cancer: A protocol for systematic review and meta-analysis

Abstract

Background: Gastric cancer (GC) has high incidence and mortality worldwide, and peritoneal metastasis is a primary cause of mortality in patients. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a feasible and effective treatment. Traditional Chinese Medicine (TCM) therapies have been combined with HIPEC for certain therapeutic advantages, but there is a lacking of evidence of evidence-based medicine. Therefore, we provide a protocol to evaluate the efficacy and safety of TCM therapies combined with HIPEC in the treatment for peritoneal metastasis of GC.

Methods and analysis: From inception until December 2020, a systematic and comprehensive literature search will be conducted in both 3 English databases and 4 Chinese databases. Randomized controlled trials (RCTs) will be included related to TCM therapies combined with HIPEC in the treatment for peritoneal metastasis of GC. Two researchers independently conducted data extraction and literature quality evaluation. The methodological qualities, including the risk of bias, will be evaluated using the Cochrane risk of bias assessment tool, while confidence in the cumulative evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Results: This study assessed the efficacy and safety of TCM therapies combined with HIPEC in the treatment of peritoneal metastasis of GC by effective rate, Karnofsky Performance Status (KPS), Carcinoemybryonic Angtigen remission rate, and incidence of adverse reactions etc.

Conclusions: This study will provide reliable evidence-based evidence for the clinical application of TCM therapies combined with HIPEC in the treatment for peritoneal metastasis of GC.

Ethics and dissemination: Ethical approval is not required, as this study is based on the review of published research. This review will be published in a peer-reviewed journal and disseminated both electronically and in print.

Registration number: INPLASY2020120048.