本研究报告了武汉UHGI001 II期试验中接受新辅助化疗和免疫治疗的局部晚期胃和胃食管交界处（G/GEJ）腺癌患者的2年结局和生物标志物分析结果。符合条件的cT3/4aN M0局部晚期G患者对 /GEJ 腺癌进行筛查、入组，并使用 3 个周期的替雷利珠单抗和 SOX 新辅助治疗，随后进行 D2 胃切除术和另外 5 个周期的术后辅助 SOX。主要终点是主要病理缓解。在 49 例纳入患者中，24 例（49.0%）实现主要病理缓解，13 例（26.5%）实现病理完全缓解。在中位随访 26.8 个月期间，2 年无进展生存率 (PFS) 和总生存率 (OS) 分别为 69.4% 和 81.2%。新辅助治疗期间有 6 名患者（12.2%）发生了 3-4 级不良事件，术后发生了 8 名患者（17.0%），辅助治疗期间有 7 名患者（15.2%）发生了 3-4 级不良事件。生物标志物分析显示，病理完全缓解与 2 年 PFS 和 OS 无关。主要病理反应显示与 2 年 PFS 和 OS 率改善存在潜在的密切关联。此外，术前循环肿瘤细胞结合病理反应有助于预后评估。此外，我们的结果表明，T 降期、淋巴细胞与单核细胞比率和 CD3 T 细胞是影响 PFS 的独立因素。印戒细胞成分（SRCC）、T 降期和中性粒细胞与淋巴细胞比率是影响 OS 的独立因素。基于多变量 Cox 回归结果构建的 PFS 和 OS 预后列线图显示了适当的校准和辨别能力。新辅助替雷利珠单抗加 SOX 在局部晚期 G/GEJ 腺癌患者中表现出良好的疗效和可接受的毒性。此外，我们的研究根据临床病理学特征建立了预后风险特征和列线图，可以准确预测患者结果并帮助制定个性化治疗计划。© 2024。外科肿瘤学会。

This study reports the 2-year outcomes and biomarker analysis results of patients with locally advanced gastric and gastroesophageal junction (G/GEJ) adenocarcinoma who received neoadjuvant chemotherapy and immunotherapy in a phase II WuhanUHGI001 trial.Eligible patients with cT3/4aN+M0 locally advanced G/GEJ adenocarcinoma were screened, enrolled, and treated with 3 cycles of neoadjuvant tislelizumab and SOX followed by D2 gastrectomy and another 5 cycles of postoperative adjuvant SOX. The primary endpoint was major pathological response.Of the 49 included patients, 24 (49.0%) achieved major pathological response and 13 (26.5%) achieved pathological complete response. During a median follow-up of 26.8 months, the 2-year progression-free survival (PFS) and overall survival (OS) rates were 69.4% and 81.2%, respectively. Grade 3-4 adverse events occurred in six patients (12.2%) during the neoadjuvant period, eight patients (17.0%) during the postoperative period, and seven patients (15.2%) during the adjuvant period. Biomarker analysis revealed that the pathological complete response showed no association with 2-year PFS and OS. Major pathological response showed a potentially strong association with improved 2-year PFS and OS rates. In addition, preoperative circulating tumor cells combined with pathological responses are helpful in prognosis assessment. In addition, our results showed that T downstaging, lymphocyte-to-monocyte ratio, and CD3+ T cells were independent factors that affect PFS. The signet ring cell component (SRCC), T downstaging, and neutrophil-to-lymphocyte ratio were independent factors affecting OS. Prognostic nomograms of PFS and OS constructed based on the multivariate Cox regression results demonstrated suitable calibration and discrimination ability.Neoadjuvant tislelizumab plus SOX exhibits promising efficacy and acceptable toxicity in patients with locally advanced G/GEJ adenocarcinoma. In addition, our study established a prognostic risk signature and nomograms based on clinicopathological characteristics, which can accurately predict patient outcomes and aid in personalized treatment planning.© 2024. Society of Surgical Oncology.