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Cancer, Stress, Anesthesia, and Immune Response / Gastric Cancer Management and Outcomes · Journal article
Frontiers in Oncology · August 14, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a protocol for a planned multicenter RCT comparing Shenqi Fuwei granules plus perioperative therapy versus placebo plus perioperative therapy in locally advanced gastric cancer, with event-free survival as the primary endpoint. No results are reported; this document establishes the intended design, population, and outcomes before trial completion.
Prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial. Perioperative patients with locally advanced gastric cancer (LAGC) recruited from multiple hospitals in China.. Intervention: Shenqi Fuwei granules (SQFWG) combined with perioperative therapy (chemotherapy ± immunotherapy). Compared with: Placebo (containing 5% SQFWG) combined with perioperative therapy (chemotherapy ± immunotherapy). n = 286. Multiple hospitals in China.
Planned sample size: 286 perioperative LAGC patients (1:1 randomization to SQFWG or placebo, each n=143) Primary endpoint: event-free survival assessed over 3-year follow-up (every 3 months after treatment completion or endpoint event) Secondary outcomes include overall survival, cumulative 1-/2-/3-year recurrence and metastasis rates, surgical conversion rate, quality of life, and safety
Secondary outcomes include overall survival, cumulative 1-/2-/3-year recurrence and metastasis rates, surgical conversion rate, quality of life, and safety
This protocol establishes a rigorous framework for testing whether Traditional Chinese Medicine (Shenqi Fuwei granules) combined with standard perioperative therapy improves event-free survival in LAGC. Clinicians should await completion and results before adopting SQFWG into practice, as this document contains no efficacy or safety data.
This is a published protocol for a planned RCT that has not yet reported results; it describes intended design and methods but provides no efficacy or safety data.
As stated by the source record.
Quoted from the source exactly as published.
This protocol establishes a rigorous framework for testing whether Traditional Chinese Medicine (Shenqi Fuwei granules) combined with standard perioperative therapy improves event-free survival in LAGC. Clinicians should await completion and results before adopting SQFWG into practice, as this document contains no efficacy or safety data.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
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.
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