Kadota Tomohiro, Fujii Rika, Koyama Shohei, Kotani Daisuke, Yoda Yusuke, Fukutani Miki, Suzuki Mitsuko, Wakabayashi Masashi, Ikeno Takashi, Sunakawa Hironori, Nakamura Yoshiaki, Kawazoe Akihito, Irie Takuma, Fuse Nozomu, Sato Akihiro, Yano Tomonori, Shitara Kohei
Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Kashiwa, Japan.
Division of Cancer Immunology, Research Institute/Exploratory Oncology Research and Clinical Trial Center (EPOC), National Cancer Center, Tokyo, Chiba, Japan.
Gastric Cancer. 2025 May 15. doi: 10.1007/s10120-025-01623-9.
Photoimmunotherapy with ASP-1929 (cetuximab conjugated to IRDye 700DX) and 690-nm red light has shown promising results, with a 43% objective response rate (ORR) in a phase IIa trial for recurrent head and neck squamous cell carcinoma. This study aimed to evaluate the safety and efficacy of combining photoimmunotherapy with nivolumab for advanced gastric cancer.
This phase Ib open-label, single-center trial investigated the combination of photoimmunotherapy with ASP-1929 and nivolumab in patients with unresectable EGFR-positive gastric adenocarcinoma after standard chemotherapy. The dose-escalation part aimed to determine the recommended dose of laser illumination energy under endoscopy, and the expansion part assessed the safety and efficacy at the determined dose. The primary endpoint was dose-limiting toxicity (DLT), and treatment response and adverse events were evaluated.
Between October 2019 and April 2022, 21 patients were enrolled. All patients had previously received at least two lines of chemotherapy, with six being refractory to anti-PD-1 therapy. No DLT was observed, and the recommended dose was 100 J/cm. Two patients achieved a partial response, and ORR was 9.5%.
This study demonstrated that combining endoscopic photoimmunotherapy with nivolumab is safe and feasible for advanced gastric cancer.
The trial is registered in the Japanese Registry of Clinical Trials (identifier: jRCT2080224884, https://jrct.niph.go.jp/en-latest-detail/jRCT2080224884 ).
使用ASP-1929（与IRDye 700DX偶联的西妥昔单抗）和690纳米红光进行的光免疫疗法已显示出有前景的结果，在复发性头颈部鳞状细胞癌的IIa期试验中客观缓解率（ORR）为43%。本研究旨在评估光免疫疗法联合纳武利尤单抗治疗晚期胃癌的安全性和疗效。
这项Ib期开放标签、单中心试验研究了光免疫疗法联合ASP-1929和纳武利尤单抗用于标准化疗后不可切除的表皮生长因子受体（EGFR）阳性胃腺癌患者。剂量递增部分旨在确定内镜下激光照射能量的推荐剂量，扩展部分评估确定剂量下的安全性和疗效。主要终点是剂量限制性毒性（DLT），并评估治疗反应和不良事件。
2019年10月至2022年4月期间，共纳入21例患者。所有患者此前至少接受过两线化疗，其中6例对抗程序性死亡蛋白1（PD-1）治疗耐药。未观察到DLT，推荐剂量为100 J/cm。2例患者实现部分缓解，ORR为9.5%。
本研究表明，内镜光免疫疗法联合纳武利尤单抗治疗晚期胃癌安全可行。
该试验已在日本临床试验注册中心注册（标识符：jRCT2080224884，https://jrct.niph.go.jp/en-latest-detail/jRCT2080224884 ）。
