Recent years have seen breakthrough progress in the use of immune checkpoint inhibitors in cancer therapy, offering new hope for patients with advanced gastric cancer. However, there remains insufficient real-world evidence regarding the efficacy and safety of combining immune checkpoint inhibitors with anti-angiogenic drugs and chemotherapy in the second-line setting. There is a pressing clinical need for dedicated studies to validate its application value. The present investigation systematically evaluated the clinical efficacy and safety profile of a multimodal therapeutic strategy integrating second-line immunotherapeutic agents, cytotoxic chemotherapy, and anti-angiogenic therapy in patients with metastatic gastroesophageal junction adenocarcinoma. A retrospective analysis was conducted on 84 patients treated in the oncology department. Patients were divided into two groups: the observation group (sintilimab + apatinib + albumin-bound paclitaxel, n = 42) and the control group (apatinib + albumin-bound paclitaxel, n = 42). Outcomes included median overall survival (mOS), median progression-free survival (mPFS), objective response rate (ORR), disease control rate (DCR), and adverse event incidence. Baseline characteristics (age, gender, Eastern Cooperative Oncology Group score, tumor location, histology, Lauren classification, human epidermal growth factor receptor 2 status, programmed death-ligand 1 expression, metastatic status, and prior treatment) showed no significant differences (P > 0.05), ensuring comparability. After follow-up, there was no significant difference in ORR or DCR between the two groups (P > 0.05): the observation group exhibited an ORR of 42.85% and DCR of 85.71%, compared to 38.09% and 75.57% in the control group, respectively. Furthermore, there was no significant difference in the overall incidence of adverse events or immune-related adverse events between the groups (P > 0.05). The incidence of immune-related adverse events was 21.43% (observation group) vs. 23.81% (control group), with no statistical significance (P = 0.798). The observation group had significantly longer mPFS (12.0 months vs. 9.0 months, hazard ratio (HR) = 0.455, 95% confidence interval [CI]: 0.217-0.956; P = 0.028), though mOS showed no difference (HR = 0.384, 95% CI: 0.131-1.125; P = 0.062). Kaplan-Meier analysis confirmed superior PFS in the observation group. The combination of an anti-PD-1 monoclonal antibody with chemotherapy and anti-angiogenic agents demonstrated preliminary efficacy and favorable safety in second-line gastric cancer patients. This study, using real-world data, validates the clinical benefit of this triple regimen, addresses the evidence gap in second-line treatment options, provides new insights for personalized combination strategies in advanced gastric cancer, and holds significant value for guiding clinical practice.
山东省济南市章丘区文博路2号
齐鲁师范学院 genelibs生信实验室
山东省济南市高新区舜华路750号
大学科技园北区F座4单元2楼
电话: 0531-88819269