Randomized Controlled Trial
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Jan 15, 2025; 17(1): 99272
Published online Jan 15, 2025. doi: 10.4251/wjgo.v17.i1.99272
Effects of Shenqi Xiangyi granules in advanced gastric cancer chemotherapy
Xiao-Jing Shi, Yu Song, Xue-Xue Liang, Ting Chen, Huang-Yu Hao, Xue Han, Ya-Nan Chen
Xiao-Jing Shi, Yu Song, Xue-Xue Liang, Ting Chen, Huang-Yu Hao, Xue Han, Ya-Nan Chen, Department of Oncology, Zhangjiagang First People's Hospital, Suzhou 215600, Jiangsu Province, China
Co-first authors: Xiao-Jing Shi and Yu Song.
Author contributions: Shi XJ and Song Y contributed equally to this work; Shi XJ and Song Y designed the study; Shi XJ, Song Y, Liang XX, Chen T, Hao HY, Han X and Chen YN contributed to the analysis of the manuscript; Shi XJ, Song Y, Liang XX, Chen T, Hao HY, Han X and Chen YN involved in the data and writing of this article; Shi XJ and Song Y are jointly responsible for data collection, design research, and have made equal contributions to this article (so designated Shi XJ and Song Y as co first authors); All authors have read and approved the final manuscript.
Institutional review board statement: This study was reviewed and approved by the Institutional Review Board of Zhangjiagang First People's Hospital, No. 2021-Z-1254.
Clinical trial registration statement: The study was registered at the Clinical Trial Center (www.researchregistry.com) with registration number: researchregistry10707.
Informed consent statement: All study participants and their legal guardians provided written informed consent before recruitment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: No additional data is available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Ya-Nan Chen, MMed, Doctor, Department of Oncology, Zhangjiagang First People's Hospital, No. 68 Jiyang West Road, Zhangjiagang, Suzhou 215600, Jiangsu Province, China. chenyanan@126.com
Received: August 28, 2024
Revised: September 21, 2024
Accepted: October 18, 2024
Published online: January 15, 2025
Processing time: 106 Days and 1.3 Hours
Abstract
BACKGROUND

Owing to the absence of specific symptoms in early-stage gastric cancer, most patients are diagnosed at intermediate or advanced stages. As a result, treatment often shifts from surgery to other therapies, with chemotherapy and targeted therapies being the primary options for advanced gastric cancer treatment.

AIM

To investigate both treatment efficacy and immune modulation.

METHODS

A total of 116 patients with advanced gastric cancer, admitted from January 2021 to December 2023, were selected and divided into two groups of 58 each using the random number table method. The control group received FOLFOX4 chemotherapy (oxaliplatin + calcium + folinate + 5-fluorouracil) combined with intravenous sindilizumab. The observation group received the same treatment as the control group, supplemented by oral administration of Senqi Shiyiwei granules. Both groups underwent treatment cycles of 3 weeks, with a minimum of two cycles. The therapeutic efficacy, immune mechanisms, and treatment-related toxicity and side effects were compared between the groups.

RESULTS

The objective remission rate in the observation group (55.17%) was higher than that of the control group (36.21%) (P < 0.05). After two treatment cycle, CD3+, CD4+, and CD4+/CD8+ levels were higher in the observation group compared to the control group, while CD8+, regulatory T cells, and natural killer cells were lower (P < 0.05). Additionally, the incidence of leukopenia, nausea, and vomiting was lower in observed group (P < 0.05). No significant differences were observed in the incidence of other adverse reactions (P > 0.05).

CONCLUSION

Adjuvant therapy with Shenqixian granules may enhance the efficacy of simudizumab combined with FOLFOX4 chemotherapy in advanced gastric cancer and the immune function by increasing immune cell counts, making it a valuable option in clinical treatment.

Keywords: Sindilizumab; FOLFOX4 chemotherapy; Advanced gastric cancer; Ginseng Qi Xiangyi granule; Clinic treatment

Core Tip: Reasonable and effective treatment with traditional Chinese medicine is crucial for patients with advanced cancer, especially those receiving chemotherapy and targeted therapy.