Abstract
BACKGROUND: Apatinib and immune checkpoint inhibitors (ICIs) have shown promise as third-line treatments for advanced gastric cancer (AGC). This study compared the efficacy and safety of apatinib combined with ICIs versus apatinib monotherapy in AGC patients after second-line treatment failure. METHODS: We conducted a retrospective analysis of 48 AGC patients with postoperative recurrence/metastasis treated at Zhejiang Provincial People's Hospital between January 2018 and September 2022. Patients received either apatinib plus ICIs (n=23) or apatinib alone (n=25). Primary endpoints were overall survival (OS) and progression-free survival (PFS); Secondary endpoints included safety and subgroup analyses. RESULTS: With median follow-up of 4.25 months, the combination group showed significantly longer median OS (6.0 vs 3.0 months, HR=0.44, 95%CI 0.24-0.82, P=0.009) and PFS (3.0 vs 2.0 months, P=0.155). Subgroup analysis revealed patients with liver metastasis receiving combination therapy had superior OS (7.5 vs 4.0 months, P=0.036). The objective response rate was higher with combination therapy (4.3% vs 0%), though not statistically significant (P=0.292). Safety profiles were comparable between groups, with no significant increase in severe adverse events with combination therapy. CONCLUSION: Apatinib combined with ICIs demonstrated improved survival outcomes compared to apatinib monotherapy in AGC, particularly for patients with liver metastasis, without increasing severe toxicity.