Frontiers in immunology · 2026
Efficacy and safety of thymosin α1 combined with chemotherapy for gastric cancer: a systematic review and meta-analysis of randomized controlled trials.
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Wang Zekun, Sun Tao, Qu Haoran, Zhao Ruping, Shan Xishen, Liu Yu, Zheng Yuling
Аннотация
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+% (WMD = 7.73), CD4+% (WMD = 6.87), CD4+/CD8+ (WMD = 0.42), and NK cell (WMD = 4.73). Regarding tumor markers, combination therapy resulted in lower levels of CEA (WMD = -5.48) and CA199 (WMD = -9.06). Regarding inflammatory factors, combination therapy may reduce levels of MMP-2, MMP-9, IL-4, and IL-10, while increasing levels of IFN-γ and TNF-α. Regarding safety, combination therapy was associated with reductions in gastrointestinal reactions (RR = 0.63), myelosuppression (RR = 0.60), abnormal liver function (RR = 0.54), and neurotoxicity (RR = 0.47). However, included RCTs did not systematically report long-term survival outcomes, and their methodological quality was limited; and GRADE indicated that quality of evidence for outcomes ranged from very low to moderate.
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.
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+% (WMD = 7.73), CD4+% (WMD = 6.87), CD4+/CD8+ (WMD = 0.42), and NK cell (WMD = 4.73). Regarding tumor markers, combination therapy resulted in lower levels of CEA (WMD = -5.48) and CA199 (WMD = -9.06). Regarding inflammatory factors, combination therapy may reduce levels of MMP-2, MMP-9, IL-4, and IL-10, while increasing levels of IFN-γ and TNF-α. Regarding safety, combination therapy was associated with reductions in gastrointestinal reactions (RR = 0.63), myelosuppression (RR = 0.60), abnormal liver function (RR = 0.54), and neurotoxicity (RR = 0.47). However, included RCTs did not systematically report long-term survival outcomes, and their methodological quality was limited; and GRADE indicated that quality of evidence for outcomes ranged from very low to moderate.
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.