Effect of Immune Checkpoint Inhibitors Combined with Oral Immunonutrition on Neoadjuvant Efficacy in Locally Advanced Gastric Cancer: Study Protocol of a Single-Center, Randomised Clinical Trial

BACKGROUND:In recent years, immune checkpoint inhibitors have played a crucial role in neoadjuvant treatment of gastric cancer, but their efficacy still needs to be improved. Immunonutrition not only reduces the incidence of malnutrition but also enhances the tolerance to neoadjuvant treatment and strengthens the immune function, making it a potential immunotherapy sensitizing agent. Therefore, this study aimed to explore whether immunonutrition therapy could enhance the efficacy of gastric cancer immunotherapy by reshaping the tumor immune microenvironment, providing new ideas and schemes for the neoadjuvant therapy of locally advanced gastric cancer (LAGC). METHODS:This study is a pragmatic, open label, single-center randomised controlled study. Suitable LAGC patients were screened and randomly assigned in a 1:1 ratio to the control group - neoadjuvant chemotherapy (NAC) and the intervention group - neoadjuvant chemotherapy combined with immunotherapy and oral immunonutrition (NACII). The primary endpoint is pathological complete response after 3 cycle treatment. The following secondary endpoints will be evaluated: R0 resection rate; lymph node status after neoadjuvant therapy; The safety of the treatment plan. The accompanying changes in the immune status and tumor microenvironment is set as the exploratory endpoint. 76 LAGC at least is expected to include in this study. DISCUSSION:The present study is the first prospective trial to evaluate the effectiveness of immunocheckpoint inhibitors combined with oral immunonutrition on neoadjuvant efficacy in LAGC. This trial may provide valuable insights for enhancing immunotherapy and establish new strategies for the neoadjuvant treatment of LAGC.