SYSTEMATIC REVIEW article
Front. Pharmacol.
Sec. Ethnopharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1661503
This article is part of the Research TopicIntegrative OMICS Approaches in Cancer Biology: From Molecular Mechanisms to Precision MedicineView all articles
Efficacy and safety of traditional Chinese medicine (TCM) combined with immune checkpoint inhibitors (ICIs) for the treatment of cancer: A Systematic Review and Meta-Analysis
Provisionally accepted
Yani Ke1
Yuyan Pan1Xueru Huang1Xing Bai1Xiaojuan Liu1Mingsi Zhang1Yunhai Wei2Tao Jiang1
Guangji Zhang1*- 1Zhejiang Chinese Medical University, Hangzhou, China
- 2Huzhou Central Hospital, Huzhou, China
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Background: Cancer remains a major global health burden. Combining traditional Chinese medicine (TCM) with immune checkpoint inhibitors (ICIs) may potentially mitigate treatment-related side effects and improve the quality of life for cancer patients. To critically evaluate the clinical efficacy of this combination therapy, a meta-analysis was performed. Methods: A systematic search was conducted across six databases. Data were analyzed using RevMan 5.3 and Stata 12. Heterogeneity was explored through subgroup analysis and meta-regression. The robustness of results was assessed via sensitivity analysis and publication bias. Results: 41 studies were included. The TCM+ICIs group demonstrated significantly superior outcomes compared to the ICIs group across multiple endpoints: Overall Response Rate (ORR) (RR: 1.34 [1.20, 1.49]), Disease Control Rate (DCR) (RR: 1.15 [1.10, 1.21]), CD4+/CD8+ T-cell ratio (WMD: 0.25 [0.15, 0.35]), Progression-Free Survival (PFS) (WMD: 0.96 [0.29, 1.63]), Overall Survival (OS) (WMD: 1.46 [0.62, 2.30]), Karnofsky Performance Status (KPS) (WMD: 6.35 [4.99, 7.70]), and TCM Therapeutic Evaluation (RR: 1.42 [1.30, 1.55]). Conversely, the TCM+ICIs group showed lower levels of tumor markers, including Alpha-Fetoprotein (AFP) (SMD: -0.75 [-1.49, - 0.01]), Carcinoembryonic Antigen (CEA) (SMD: -0.72 [-1.08, -0.37]), Carbohydrate Antigen 125 (CA125) (SMD: -0.77 [-1.46, -0.08]), and a reduced incidence of adverse events (RR: 0.82 [0.69, 0.97]). There is high heterogeneity among CD4+T/CD8+T studies due to the type of tumor and whether it is combined with chemotherapy. The high heterogeneity among studies on KPS may be related to the type of ICIs. Sensitivity analysis and assessment of publication bias confirmed the robustness of the pooled results. Conclusion: The combination of TCM with ICIs appears to enhance antitumor immunity, reduce adverse reactions, lower serum tumor marker levels, improve disease control, and ameliorate patient performance status. This combination strategy represents a promising therapeutic approach for various cancers and warrants further investigation.
Keywords: TCM, Traditional Chinese Medicine, ICIS, immune checkpoint inhibitors, Cancer, Meta-analysis
Received: 23 Jul 2025; Accepted: 17 Oct 2025.
Copyright: © 2025 Ke, Pan, Huang, Bai, Liu, Zhang, Wei, Jiang and Zhang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Guangji Zhang, zgjtcm@zcmu.edu.cn
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