Objective  To investigate the efficacy and safety of Sintilimab combined with SOX regimen in the treatment of patients with advanced gastric cancer.

Methods  The clinical data of patients with advanced gastric cancer in Wuxi Branch, Ruijin Hospital, Shanghai Jiaotong University School of Medicine from January 2020 to January 2024 were retrospectively collected. According to the treatment methods, the patients were divided into two groups. The treatment group was treated with Sintilimab combined with SOX regimen, while the control group was treated with SOX regimen alone. The objective response rate (ORR), median progressionfree survival (PFS), median overall survival (OS), incidence of adverse reactions and quality of life were compared between the two groups.

Results  A total of 115 patients with advanced gastric cancer were included, 52 in the treatment group and 63 in the control group. The ORR of the treatment group was significantly higher than that of the control group (59.62% vs. 38.10%, P<0.05). Stratified analysis showed that in patients with PD-L1 CPS≥5, the ORR of treatment group was significantly higher than that of control group (73.91% vs. 37.50%, P<0.05). The median follow-up time was 37.0 months. Survival analysis showed that the median PFS (9.3 months vs. 8.1 months) and the median OS (16.0 months vs. 12.8 months) in the treatment group were significantly better than those in the control group (P<0.05). In patients with PD-L1 CPS≥5, the median PFS (10.2 months vs. 7.0 months) and median OS (17.2 months vs. 11.0 months) in the treatment group were more obvious than those in the control group (P<0.05). The improvement rate of quality of life in the treatment group was significantly higher than that in the control group (51.92%, vs. 23.81%, P<0.05). There was no statistical difference in the incidence of grade III~IV side effects between the two groups (P>0.05).

Conclusion  In patients with advanced gastric cancer, the Sintilimab combined with the SOX regimen has higher clinical efficacy, significantly prolonging the PFS and OS of patients, improving prognosis, and enhancing quality of life. However, adverse effects have not increased  significantly.

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