Qin HY, Li Z, Cong PW, Mi D, Li FZ, Hu X, Li GX. Clinical efficacy of Fuzheng Jiedu Xiaoyong granules in advanced colorectal cancer (spleen deficiency and stasis toxin syndrome). World J Gastrointest Oncol 2026; 18(2): 113922 [DOI: 10.4251/wjgo.v18.i2.113922]
Corresponding Author of This Article
Guo-Xin Li, PhD, Chief Physician, Professor, Guoyi Hall, The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, No. 60 Huanghe North Street, Huanggu District, Shenyang 110034, Liaoning Province, China. syyljdlgx024@126.com
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Oncology
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Clinical Trials Study
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This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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: http://creativecommons.org/licenses/by-nc/4.0/
Feb 15, 2026 (publication date) through Feb 3, 2026
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World Journal of Gastrointestinal Oncology
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1948-5204
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Qin HY, Li Z, Cong PW, Mi D, Li FZ, Hu X, Li GX. Clinical efficacy of Fuzheng Jiedu Xiaoyong granules in advanced colorectal cancer (spleen deficiency and stasis toxin syndrome). World J Gastrointest Oncol 2026; 18(2): 113922 [DOI: 10.4251/wjgo.v18.i2.113922]
World J Gastrointest Oncol. Feb 15, 2026; 18(2): 113922 Published online Feb 15, 2026. doi: 10.4251/wjgo.v18.i2.113922
Clinical efficacy of Fuzheng Jiedu Xiaoyong granules in advanced colorectal cancer (spleen deficiency and stasis toxin syndrome)
Hai-Yun Qin, Zheng Li, Pei-Wei Cong, Dan Mi, Feng-Zhen Li, Xin Hu, Guo-Xin Li
Hai-Yun Qin, Second Clinical College, Liaoning University of Traditional Chinese Medicine, Shenyang 110031, Liaoning Province, China
Hai-Yun Qin, Dan Mi, Feng-Zhen Li, Xin Hu, Department of Oncology, The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110034, Liaoning Province, China
Zheng Li, Department of Integrated Traditional Chinese and Western Medicine, Liaoning Cancer Hospital & Institute, Shenyang 110847, Liaoning Province, China
Pei-Wei Cong, Teaching Experiment Center, Liaoning University of Traditional Chinese Medicine, Shenyang 110031, Liaoning Province, China
Guo-Xin Li, Guoyi Hall, The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110034, Liaoning Province, China
Author contributions: Qin HY and Li GX designed the research study; Qin HY, Li Z, Li FZ, Hu X and Mi D performed the research; Qin HY, Li Z, Cong PW and Mi D contributed new reagents and analytic tools; Qin HY and Mi D analyzed the data and wrote the manuscript; all authors have read and approve the final manuscript.
Institutional review board statement: The study was reviewed and approved by the Ethics Committee of The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine [Approval No. 2023(XS)-003-02(FS)].
Clinical trial registration statement: This study is registered at http://itmctr.ccebtcm.org.cn. The registration identification number is ITMCTR2025002274.
Informed consent statement: All study participants provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All authors of this manuscript declare that they have no conflicts of interest in this study.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Data sharing statement: Technical appendix, statistical code, and dataset were available from the first author at hyman_825@163.com.
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: Guo-Xin Li, PhD, Chief Physician, Professor, Guoyi Hall, The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, No. 60 Huanghe North Street, Huanggu District, Shenyang 110034, Liaoning Province, China. syyljdlgx024@126.com
Received: October 14, 2025 Revised: November 21, 2025 Accepted: December 18, 2025 Published online: February 15, 2026 Processing time: 111 Days and 17.4 Hours
Abstract
BACKGROUND
The management of advanced colorectal cancer (CRC) is challenging due to limited treatment efficacy and the significant toxicities and resistance associated with chemotherapy. Traditional Chinese medicine offers potential therapeutic benefits through mechanisms such as inhibiting tumor proliferation, modulating immunity, and preventing angiogenesis. Fuzheng Jiedu Xiaoyong granules (FZJDXYG) has shown promising clinical results, including enhanced immune function and reduced chemotherapy-related toxicities.
AIM
To validate the efficacy and safety of FZJDXYG and determine its effects on immune function in patients with advanced CRC.
METHODS
In this multi-center, double-blind, randomized, placebo-controlled trial, 78 eligible patients were randomly assigned at a ratio of 1:1 to the treatment group (receiving FZJDXYG plus standard care) or the control group (receiving placebo plus standard care) for 12 weeks.
RESULTS
The treatment group experienced significant reductions in carcinoembryonic antigen and carbohydrate antigen 19-9 levels (both P < 0.05), with significantly greater reductions in these two markers compared to the control group (both P < 0.05). Immunologically, the treatment group exhibited significant increases in CD3+ and CD4+ cell counts and CD4+/CD8+ ratio, and decreased CD8+ levels, with all changes superior to those in the control group (all P < 0.05). The Karnofsky Performance Status score was also significantly higher in the treatment group (P < 0.05). Crucially, the incidence of adverse events was significantly lower in the treatment group than in the control group (P < 0.05).
CONCLUSION
FZJDXYG effectively ameliorates clinical symptoms, enhances immune function, and reduces chemotherapy-induced toxicities in patients with advanced CRC with spleen deficiency and stasis toxin syndrome.
Core Tip: The combination of Fuzheng Jiedu Xiaoyong granules (FZJDXYG) with first-line therapy for advanced colorectal cancer (CRC) demonstrates significant clinical efficacy with minimal adverse effects. It can effectively modulate immune dysfunction and improve patients’ quality of life. A parallel, randomized, controlled trial confirmed the significant efficacy and high safety of FZJDXYG in treating advanced CRC patients. Moreover, FZJDXYG significantly increased CD4+ T cell abundance, reduced CD8+ T cell abundance, and increased the CD4+/CD8+ ratio in patients, with significant differences before and after treatment, as well as between the treatment and control group.
