Efficacy and safety of Cadonilimab in the treatment of recurrent/metastatic and advanced cervical cancer: a systematic review and meta-analysis

Objective: To investigate the efficacy and safety of Cadonilimab in patients with metastatic, recurrent, and advanced cervical cancer. Methods: Computerized searches were performed in PubMed, Embase, Cochrane Library, Wiley Online Library, Web of Science, and the CBM database from their inception until October 4, 2025, to collect published studies on Cadonilimab for cervical cancer. A single-arm rate meta-analysis was conducted using R software (version 4.4.1) to evaluate outcome measures including efficacy, safety, and prognostic indicators. Results: Ten studies involving 728 patients were included. The meta-analysis yielded the following pooled results: the overall response rate (ORR) was 57.8% (95% CI = 44.5%-70.2%), the disease control rate (DCR) was 81.8% (95% CI = 69.5%-89.9%), the complete response (CR) rate was 16.1% (95% CI = 10.2%-24.4%), and the partial response (PR) rate was 37.4% (95% CI = 28.6%-47.2%). The rates of stable disease (SD) and progressive disease (PD) were 19.8% (95% CI = 13.6%-27.9%) and 18.2% (95% CI = 10.1%-30.5%), respectively. The 6-month, 12-month, and 24-month overall survival (OS) rates were 78%, 78%, and 62%, respectively, while the 6-month and 12-month progression-free survival (PFS) rates were 53% and 48%, respectively. Regarding safety, the incidence of any-grade treatment-related adverse events (TRAEs) was 96.4% (95% CI = 75.5%-99.6%), the rate of grade ≥3 adverse events was 41.1% (95% CI = 25.2%-59.1%), and immune-related adverse events (irAEs) occurred in 38.6% (95% CI = 23.0%-56.9%) of patients. Conclusion: This meta-analysis suggests that Cadonilimab is associated with antitumor activity and a manageable safety profile in patients with recurrent, metastatic, and advanced cervical cancer. Close monitoring for irAEs, vigilance against adverse events, and timely pharmacological intervention are essential during treatment to mitigate risks and achieve optimal therapeutic outcomes. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO, identifier CRD420251168672.