Wakabayashi Munehiro, Masuishi Toshiki, Ogata Takatsugu, Hanamura Fumiyasu, Furuta Mitsuhiro, Yamamoto Yoshiyuki, Kawakami Kentaro, Hirano Hidekazu, Kito Yosuke, Izawa Naoki, Takahashi Naoki, Matsumoto Toshihiko, Kawakami Hisato, Ando Takayuki, Minashi Keiko, Kudo Chiho, Yoshimura Kenichi, Muro Kei
Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Department of Gastroenterology and Hepatology, Faculty of Medicine, Toho University, Tokyo, Japan.
Future Oncol. 2025 Jul;21(17):2135-2141. doi: 10.1080/14796694.2025.2514935. Epub 2025 Jun 6.
Advanced gastric cancer (AGC) patients with severe peritoneal metastases (SPM), characterized by massive ascites and/or inadequate oral intake, have a poor prognosis with the median overall survival of around 7 months, even when treated with fluorouracil/l-leucovorin plus oxaliplatin (mFOLFOX6), despite being a treatment options for these patients demonstrated in the WJOG10517G study. However, these patients were excluded from pivotal Phase III trials, including the CheckMate 649 study, which demonstrated the benefit of adding nivolumab to mFOLFOX6, due to tumor-related complications. Given the lack of data on the efficacy and safety of combining nivolumab with mFOLFOX6 for AGC patients with SPM, we initiated a Phase II study to evaluate this combination. The primary endpoint was the 1-year survival rate. Japan Registry of Clinical Trials (jRCTs) 041220164.
伴有严重腹膜转移（SPM）的晚期胃癌（AGC）患者，其特征为大量腹水和/或经口摄入量不足，预后较差，中位总生存期约为7个月，即便接受氟尿嘧啶/亚叶酸钙联合奥沙利铂（mFOLFOX6）治疗也是如此，尽管WJOG10517G研究表明该治疗方案适用于这些患者。然而，由于肿瘤相关并发症，这些患者被排除在关键的III期试验之外，包括CheckMate 649研究，该研究证明了在mFOLFOX6基础上加用纳武利尤单抗的益处。鉴于缺乏关于纳武利尤单抗与mFOLFOX6联合用于伴有SPM的AGC患者的疗效和安全性的数据，我们启动了一项II期研究来评估这种联合治疗方案。主要终点是1年生存率。日本临床试验注册中心（jRCTs）041220164。
