Kodama Hiroyuki, Narita Yukiya, Nakamura Michio, Takahashi Masanobu, Mizukami Takuro, Ando Takayuki, Mitani Seiichiro, Komori Azusa, Hosokawa Ayumu, Moriwaki Toshikazu, Sugiyama Keiji, Taguri Masataka, Orihara Shunichiro, Kagamu Hiroshi, Yamaguchi Toshifumi, Nishikawa Hiroki, Muro Kei
Cancer Chemotherapy Center, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Department of Gastroenterology, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Future Oncol. 2025 Jun;21(14):1753-1759. doi: 10.1080/14796694.2025.2500918. Epub 2025 May 8.
Combination treatment with an anti-programmed cell death-1 (PD-1) antibody, an immune checkpoint inhibitor (ICI), and chemotherapy is the standard treatment for patients with HER2-negative advanced gastric/esophagogastric cancer (AGC). ICI re-administration has been reported to have a clinical benefit for patients with lung cancer or melanoma. However, data on patients with AGC have not yet been collected. We plan to conduct a prospective, multicenter, observational NIVO RETURNS study to evaluate the efficacy and safety of nivolumab monotherapy re-administration in patients with AGC refractory to initial anti-PD-1 or anti-programmed cell death ligand-1 (PD-L1) antibody treatment. Patients who have achieved clinical benefits (complete response, partial response, or stable disease for ≥ 6 months) from prior treatment, including anti-PD-1/PD-L1 therapy, will be included. The primary endpoint will be the objective response rate to nivolumab re-administration. We anticipate that our findings will contribute to the improvement of survival outcomes as later-line treatment for AGC. UMIN000050515, UMIN000051044.
抗程序性细胞死亡蛋白1（PD-1）抗体、免疫检查点抑制剂（ICI）与化疗联合治疗是HER2阴性晚期胃癌/食管胃交界癌（AGC）患者的标准治疗方案。据报道，ICI再次给药对肺癌或黑色素瘤患者具有临床益处。然而，尚未收集到AGC患者的数据。我们计划开展一项前瞻性、多中心、观察性NIVO RETURNS研究，以评估纳武利尤单抗单药再次给药对初始抗PD-1或抗程序性细胞死亡配体1（PD-L1）抗体治疗难治的AGC患者的疗效和安全性。曾从包括抗PD-1/PD-L1治疗在内的既往治疗中获得临床益处（完全缓解、部分缓解或疾病稳定≥6个月）的患者将被纳入研究。主要终点将是纳武利尤单抗再次给药的客观缓解率。我们预计我们的研究结果将有助于改善AGC后线治疗的生存结局。UMIN000050515，UMIN000051044。
