Efficacy of a phlegm-resolving traditional Chinese medicine regimen in advanced gastric cancer: A retrospective observational study
Introduction: Traditional Chinese medicine has been shown to improve survival and immune function in patients with advanced gastric cancer (AGC).
Objectives: This study aimed to evaluate the efficacy of a phlegm-resolving regimen (Ziyin Huatan recipe combined with Xiaoaiping injection) and syndrome differentiation-guided therapy combined with various antineoplastic Chinese patent medicine injections in AGC.
Methods: Data from 150 patients with AGC were retrospectively analyzed: 75 in the study group and 75 in the control group. The clinical data were analyzed, including Karnofsky Performance Status (KPS), 1-, 2-, and 3-year survival rates, overall survival (OS), median OS, progression-free survival (PFS), and median PFS.
Results: At 3 months, the mean KPS score significantly increased from 55.33 ± 6.44 to 73.07 ± 8.70 in the study group (p = 0.001 [< 0.01]), and from 54.93 ± 6.23 to 72.40 ± 8.67 (p = 0.001 [< 0.01]) in the control group. There was no significant difference in the changes of KPS score between the two groups. The median OS was 17.0 months in the study group (95% confidence interval [CI]: 13.16–20.84) versus 14.7 months in the control group (95% CI: 8.89–20.51). There was no significant difference in the OS between the two groups. The median PFS was 16.0 months in the study group (95% CI: 11.17–16.83) versus 12.0 months in the control group (95% CI: 7.48–16.52). The 1-year and 3-year PFS rates in the study group were higher than in the control group (61.33% versus 49.3% and 21.3% versus 14.7%, respectively).
Conclusion: Our retrospective study suggests that phlegm-resolving regimens may confer survival benefits in patients with AGC; accordingly, such regimens can be considered for incorporation into standardized treatment strategies.
- Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi: 10.3322/caac.21834
- Zheng RS, Chen R, Han BF, et al. 2022 nian zhongguo erxing zhongliu liuxing qingkuang fenxi [Cancer incidence and mortality in China, 2022]. Zhonghua Zhong Liu Za Zhi. 2024;46(3):221-231. [In Chinese] doi: 10.3760/cma.j.cn112152-20240119-00035
- Zeng HM, Ran XH, An L, et al. Disparities in stage at diagnosis for five common cancers in China: a multicentre, hospital-based, observational study. Lancet Public Health. 2021;6(12):e877-e887. doi: 10.1016/S2468-2667(21)00157-2
- Ajani JA, D'Amico TA, Bentrem DJ, et al. Gastric Cancer, Version 2.2025, NCCN Clinical Practice Guidelines In Oncology. J Natl Compr Canc Netw. 2025;23(5):169-191. doi: 10.6004/jnccn.2025.0022
- Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2025 (7th edition). Gastric Cancer. 2026;29(2):271-299. doi: 10.1007/s10120-025-01698-4
- Zhongguo kangai xiehui weiai zhuanye weiyuanhui. 2024 ban CACA weiai zhenghe zhenzhi zhinan [Committee of Gastric Cancer, China Anti-Cancer Association. China Anti-Cancer Association guidelines for holistic integrative management of gastric cancer (2024 abridged version)]. Chin J Clin Oncol. 2024;51(13):649-657. [In Chinese] doi: 10.12354/j.issn.1000-8179.2024.20240882
- Wagner AD, Syn NL, Moehler M, et al. Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev. 2017;8(8):CD004064. doi: 10.1002/14651858.CD004064.pub4
- Chen Y, Jia KR, Xie Y, et al. The current landscape of gastric cancer and gastroesophageal junction cancer diagnosis and treatment in China: a comprehensive nationwide cohort analysis. J Hematol Oncol. 2025;18(1):42. doi: 10.1186/s13045-025-01698-y
- Biaozhunhua xiangmuzu. Weiai zhongxiyi jiehe zhenliao zhinan (2023) [Standardization Project Group. Guidelines for Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Gastric Cancer (2023)]. Chin J Integr Med. 2024;44(3):261-272. [In Chinese] doi: 10.7661/j.cjim.20240131.008
- Huang AS, Wu J, Amin A, Fu XQ, Yu ZL. Traditional Chinese medicine in treating upper digestive tract cancers. Mol Cancer. 2024;23(1):250. doi: 10.1186/s12943-024-02149-x
- Lu CC, Ke LX, Li JY, et al. Chinese Medicine as an Adjunctive Treatment for Gastric Cancer: Methodological Investigation of meta-Analyses and Evidence Map. Front Pharmacol. 2022;12:797753. doi: 10.3389/fphar.2021.797753
- Dai ZL, Tan CF, Wang J, et al. Traditional Chinese medicine for gastric cancer: An evidence mapping. Phytother Res. 2024;38(6):2707-2723. doi: 10.1002/ptr.8155
- Hu Y, Wang Z, Ni K, Yang J. Challenges in Traditional Chinese Medicine Clinical Trials: How to Balance Personalized Treatment and Standardized Research? Ther Clin Risk Manag. 2025;21:1085-1094. doi: 10.2147/TCRM.S523279
- Kong XJ, Yue XQ. Lun "Yinxu tanning dujie" shi wanqi weiai de hexin bingji [Study on "Yin deficiency combined with phlegm and toxin" is the core pathogenesis of advanced gastric cancer]. Guid J Tradit Chin Med Pharm. 2017;23(14):56-58. [In Chinese]
- Wang X, Yan YL, Chen X, et al. The Antitumor Activities of Marsdenia tenacissima. Front Oncol. 2018;8:473. doi: 10.3389/fonc.2018.00473
- Wang XW, Yue XQ. Ziyin huatanfang lianhe hualiao zhiliao wanqi weiai de liaoxiao guancha [Curative effect of Ziyin Huatan Recipe combined with chemotherapy on advanced gastric cancer]. Chin J Clin Med. 2021;28(6):1005-1010. [In Chinese] doi: 10.12025/j.issn.1008-6358.2021.20211528
- Zhou XQ, Chang YZ, Shen CY, Han J, Chang RA. Xiaoaiping injection combined with chemotherapy for advanced gastric cancer: An updated systematic review and meta-analysis. Front Pharmacol. 2022;13:1023314. doi: 10.3389/fphar.2022.1023314
- Mor V, Laliberte L, Morris JN, Wiemann M. The Karnofsky Performance Status Scale. An examination of its reliability and validity in a research setting. Cancer. 1984;53(9):2002-2007. doi: 10.1002/1097-0142(19840501)53:9%3C2002::AID-CNCR2820530933%3E3.0.CO;2-W
- Zheng KW, Lu J, Liu XL, et al. The clinical application value of the extracellular-water-to-total-body-water ratio obtained by bioelectrical impedance analysis in people with advanced cancer. Nutrition. 2022;96:111567. doi: 10.1016/j.nut.2021.111567
- Zhao LL, Chen ZH, Zhang F, Zhang FZ, et al. Changing landscape in stage, treatment and survival of gastric cancer in China 1998-2022: Insights of 40,158 patients from the National Gastric Cancer Cohort. Cancer Lett. 2026;642:218261. doi: 10.1016/j.canlet.2026.218261
- Zhang XY, Gao BA, Wang W. Early-onset gastric cancer global burden profile, trends, and contributors. Cancer Biol Med. 2025;22(10):1240-1254. doi: 10.20892/j.issn.2095-3941.2025.0320
- Luo DS, Xu HT, Jiang C, et al. The prognostic role of palliative gastrectomy in advanced gastric cancer: a systematic review and meta-analysis. BMC Cancer. 2024;24(1):1096. doi: 10.1186/s12885-024-12860-z
- Luo XF, Luo YH, Zhao XY, et al. Application and progress of palliative therapy in advanced gastric carcinomas. Front Oncol. 2023;13:1104447. doi: 10.3389/fonc.2023.1104447
- Xiu LJ, Sun DZ, Jiao JP, Yan B, Qin ZF, Liu X. Anticancer effects of traditional Chinese herbs with phlegm-eliminating properties - An overview. J Ethnopharmacol. 2015;172:155-161. doi: 10.1016/j.jep.2015.05.032
- Sun DZ, Jiao JP, Ju DW, et al. Tumor interstitial fluid and gastric cancer metastasis: an experimental study to verify the hypothesis of "tumor-phlegm microenvironment". Chin J Integr Med. 2012;18(5):350-358. doi: 10.1007/s11655-012-1085-z