Efficacy and safety of thymosin α1 combined with chemotherapy for gastric cancer: a systematic review and meta-analysis of randomized controlled trials.

Objective: To systematically evaluate the efficacy and safety of thymosin α1 combined with chemotherapy in the treatment of gastric cancer. Methods: A systematic search of 8 electronic databases was conducted to identify relevant RCTs. Meta-analysis was performed using Stata 18.0. Meta-regression, subgroup analyses, sensitivity analyses, and publication bias analyses were conducted to further examine results, and reliability of findings was assessed using TSA and GRADE. Results: 20 RCTs involving 1,704 patients were included. Meta-analysis results showed that, thymosin α1 combined with chemotherapy was associated with higher ORR (RR = 1.39), DCR (RR = 1.16), and KPS scores (WMD = 8.27). Regarding immune function, combination therapy resulted in higher CD3 Conclusion: The combination of thymosin α1 with chemotherapy is associated with improved short-term efficacy, enhanced immune function, improved quality of life, and a reduced incidence of adverse reactions in patients with gastric cancer, indicating good potential for clinical application. However, it remains unclear whether this approach can provide long-term benefits for patients with gastric cancer. Furthermore, given that studies included were all small-sample studies conducted in China and were of limited quality, certainty of evidence is low; these conclusions require further validation through additional high-quality studies. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/, Identifier CRD420261282679.