Astragalus Polysaccharides Combined with Radiochemotherapy for Cervical Cancer: A Systematic Review and Meta-analysis of Randomized Controlled Studies

Tao Sun¹Ruping Zhao²Yaling Zhang^1*Dongdong Li³Xishen Shan¹Xiaoyu Tang¹Yuling Zheng^2*

• ¹Department of Oncology, the First Affiliated Hospital Henan of University of Chinese Medicine, Zhengzhou, China
• ²Henan University of Chinese Medicine, Zhengzhou, China
• ³Henan University of Chinese Medicine Henan Provincial Hospital of TCM, Zhengzhou, China

Objective: This systematic review aims to determine the clinical efficacy and safety of Astragalus Polysaccharide Injection (APS) combined with chemoradiotherapy for cervical cancer based on existing data. Methods: Systematic searches were conducted in PubMed, Web of Science, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang Data, Chinese Scientific Journal Database (VIP), SinoMed, and China Clinical Trials Registry Platform. The search period spanned from the inception of each database to August 1, 2025. The ROB2 tool was used to evaluate the quality of included RCTs. Meta-analysis was performed using Review Manager software, and sensitivity analysis was conducted with Stata 18 software. Evidence quality was assessed using the GRADE system. Additionally, TSA was employed to calculate the final required sample size for this meta-analysis and to validate the reliability of conclusions. The protocol for this systematic review was registered and published in PROSPERO (CRD420251139830). Results: This study included 9 RCTs involving 776 patients. Meta-analysis results showed that compared with chemoradiotherapy alone, APS combined with chemoradiotherapy improved the objective response rate (ORR, RR=1.43, 95% CI: 1.24-1.64) and disease control rate (DCR, RR=1.16, 95% CI: 1.08–1.24), and Karnofsky Performance Status (KPS) score (MD = 6.64, 95% CI: 4.12–9.16). It also 3 modulates immune function: CD3⁺ T lymphocyte ratio (MD = 14.51, 95% CI: 1.64 to 27.39), CD4⁺ T lymphocyte ratio (MD = 4.87, 95% CI: 1.79 - 7.96), and CD4⁺/CD8⁺ ratio (MD = 0.25, 95% CI: 0.17 - 0.33). Furthermore, APS combined with chemoradiotherapy further reduced tumor marker levels, including: CEA (MD = -1.24, 95% CI: -1.58 to -0.89), SCC (MD = -1.18, 95% CI: -1.51 to -0.84), and CA125 (MD = -9.12, 95% CI: -18.22 to -0.01). Subgroup analyses of ORR and DCR suggest that APS can enhance the clinical efficacy of radiotherapy and chemotherapy for cervical cancer, respectively. TSA indicated that the results for ORR, DCR, and ADRs were certain, with other trials unlikely to alter the findings. Conclusion: APS combined with chemoradiotherapy improves response rates, enhances immune function, and reduces treatment-related toxicity in cervical cancer; however, confirmation through larger, high-quality multicenter RCTs is warranted.