Clinical Efficacy of Hewei Jiedu Formula Combined with SOX Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer

Corresponding author: Sun Yuanshui, 15658827828@163.com

DOI: 10.12201/bmr.202611.00014

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  Abstract: Objective To investigate the efficacy and safety of Hewei Jiedu Formula combined with S-1 plus oxaliplatin (SOX) neoadjuvant chemotherapy in patients with locally advanced gastric cancer.Methods Seventy-two patients with locally advanced gastric cancer were randomly assigned to a control group and a treatment group, with 36 patients in each group. Two patients in the control group and one in the treatment group dropped out; 34 and 35 patients, respectively, were included in the efficacy analysis. Both groups received two cycles of SOX neoadjuvant chemotherapy, and the treatment group additionally received Hewei Jiedu Formula. Tumor regression grade (TRG), radiological response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, traditional Chinese medicine (TCM) syndrome scores, and treatment-related adverse events were compared.Results Baseline characteristics were comparable between groups (all P>0.05). The TRG response rate was 32.4% (11/34) in the control group and 60.0% (21/35) in the treatment group (χ²=5.301, P=0.021). Objective response rates were 14.7% and 37.1%, and disease control rates were 70.6% and 94.3% in the control and treatment groups, respectively (P=0.034 and P=0.009). After treatment, scores for epigastric pain, poor appetite, belching, and fatigue were lower in the treatment group (all P<0.05), and the overall TCM syndrome response rate was higher (71.4% vs 44.1%, P=0.022). Leukopenia, neutropenia, and nausea/vomiting occurred less frequently in the treatment group (all P<0.05).Conclusion Hewei Jiedu Formula combined with SOX neoadjuvant chemotherapy may enhance pathological and radiological responses, improve TCM syndrome symptoms, and reduce selected hematologic and gastrointestinal toxicities in patients with locally advanced gastric cancer.

  Key words: Stomach neoplasms; Weihe Jiedu Formula; Neoadjuvant chemotherapy; SOX regimen; Tumor regression grade; Traditional Chinese medicine syndrome

  Submit time: 8 November 2026

  Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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