Neoadjuvant sintilimab in combination with concurrent chemoradiotherapy for locally advanced gastric or gastroesophageal junction adenocarcinoma: a single-arm phase 2 trial

Jia Wei, Xiaofeng Lu, Qin Liu, Yao Fu, Song Liu, Yang Zhao, Jiawei Zhou, Hui Chen, Meng Wang, Lin Li, Ju Yang, Fangcen Liu, Liming Zheng, Haitao Yin, Yang Yang, Chong Zhou, Ping Zeng, Xiaoyu Zhou, Naiqing Ding, Shiqing Chen, Xiaochen Zhao, Jing Yan, Xiangshan Fan, Wenxian Guan () and Baorui Liu ()
Additional contact information
Jia Wei: Affiliated Hospital of Medical School, Nanjing University
Xiaofeng Lu: Affiliated Hospital of Medical School, Nanjing University
Qin Liu: Affiliated Hospital of Medical School, Nanjing University
Yao Fu: Affiliated Hospital of Medical School, Nanjing University
Song Liu: Affiliated Hospital of Medical School, Nanjing University
Yang Zhao: Nanjing Medical University
Jiawei Zhou: Nanjing Medical University
Hui Chen: 3D Medicines Inc
Meng Wang: Affiliated Hospital of Medical School, Nanjing University
Lin Li: Affiliated Hospital of Medical School, Nanjing University
Ju Yang: Affiliated Hospital of Medical School, Nanjing University
Fangcen Liu: Affiliated Hospital of Medical School, Nanjing University
Liming Zheng: Affiliated Hospital of Medical School, Nanjing University
Haitao Yin: Xuzhou Central Hospital
Yang Yang: Affiliated Hospital of Medical School, Nanjing University
Chong Zhou: Xuzhou Central Hospital
Ping Zeng: Affiliated Hospital of Medical School, Nanjing University
Xiaoyu Zhou: Nanjing University of Chinese Medicine
Naiqing Ding: Affiliated Hospital of Medical School, Nanjing University
Shiqing Chen: 3D Medicines Inc
Xiaochen Zhao: 3D Medicines Inc
Jing Yan: Affiliated Hospital of Medical School, Nanjing University
Xiangshan Fan: Affiliated Hospital of Medical School, Nanjing University
Wenxian Guan: Affiliated Hospital of Medical School, Nanjing University
Baorui Liu: Affiliated Hospital of Medical School, Nanjing University

Nature Communications, 2023, vol. 14, issue 1, 1-12

Abstract: Abstract In this multicenter, single-arm phase 2 trial (ChiCTR1900024428), patients with locally advanced gastric/gastroesophageal junction cancers receive one cycle of sintilimab (anti-PD1) and chemotherapy (S-1 and nab-paclitaxel), followed by 5 weeks of concurrent chemoradiotherapy and sintilimab, and another cycle of sintilimab and chemotherapy thereafter. Surgery is preferably scheduled within one to three weeks, and three cycles of adjuvant sintilimab and chemotherapy are administrated. The primary endpoint is the pathological complete response. Our results meet the pre-specified primary endpoint. Thirteen of 34 (38.2%) enrolled patients achieve pathological complete response (95% CI: 22.2-56.4). The secondary objectives include disease-free survival (DFS), major pathological response, R0 resection rate, overall survival (OS), event-free survival (EFS), and safety profile. The median DFS and EFS were 17.0 (95%CI: 11.1-20.9) and 21.1 (95%CI: 14.7-26.1) months, respectively, while the median OS was not reached, and the 1-year OS rate was 92.6% (95%CI: 50.1-99.5%). Seventeen patients (50.0%) have grade ≥3 adverse events during preoperative therapy. In prespecified exploratory biomarker analysis, CD3+ T cells, CD56+ NK cells, and the M1/M1 + M2-like macrophage infiltration at baseline are associated with pathological complete response. Here, we show the promising efficacy and manageable safety profile of sintilimab in combination with concurrent chemoradiotherapy for the perioperative treatment of locally advanced gastric/gastroesophageal junction adenocarcinoma.

Date: 2023
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DOI: 10.1038/s41467-023-40480-x

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