Efficacy and safety of Shenqi Fuwei granule combined with perioperative regimen in the treatment of locally advanced gastric cancer: a randomized, double-blind, placebo-controlled multicenter clinical trial protocol.

BACKGROUND: While the introduction of neoadjuvant therapy has innovated perioperative treatment strategies for locally advanced gastric cancer (LAGC), preventing postoperative recurrence and metastasis remains a key clinical challenge. Previous research has indicated that Shenqi Fuwei granules (SQFWG), a Traditional Chinese medicine (TCM) prescription, possesses anti-gastric cancer properties. However, evidence from perioperative intervention studies is lacking. Our trial aims to evaluate the efficacy and safety of SQFWG combined with perioperative therapy in reducing postoperative recurrence and metastasis in LAGC, to explore clinical characteristics of the benefiting population, and to provide an evidence base for developing treatment protocols. METHODS: This is a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial. We plan to recruit 286 perioperative LAGC patients from multiple hospitals in China. Participants will be randomly assigned (1:1) using a central interactive web response system with allocation concealment, stratified by the use of neoadjuvant chemotherapy ± immunotherapy, to either the control group (n=143, placebo containing 5% SQFWG) or the experimental group (n=143, SQFWG). Both groups will concurrently receive perioperative treatment (chemotherapy ± immunotherapy). Follow-up assessments will be conducted every 3 months for 3 years after treatment completion or upon reaching an endpoint event. The primary efficacy endpoint is event-free survival. Secondary outcomes include overall survival, cumulative 1-/2-/3-year recurrence and metastasis rates, surgical conversion rate, quality of life, and safety. At the same time, prespecified subgroup analyses will be performed according to the use of immunotherapy and the type of chemotherapy regimen, and the clinical applicability of SQFWG will be further explored. DISCUSSION: To our knowledge, this is one of the first multicenter randomized double-blind placebo-controlled trials evaluating the efficacy of SQFWG in perioperative LAGC. This trial is expected to provide high-level evidence for the role of TCM in perioperative comprehensive management of LAGC. CLINICAL TRIAL REGISTRATION: https://www.ClinicalTrials.gov, identifier NCT07098026, ITMCTR2025001212.