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<p>In this phase 2 trial (NCT04744649), 17 patients with locally advanced Epstein-Barr virus-associated gastric or gastroesophageal junction adenocarcinoma (cT2-4aN1-3M0) received four cycles neoadjuvant toripalimab plus capecitabine/oxaliplatin. The primary endpoint was major pathological response; secondary endpoints included pathological complete response, R0 resection, adverse events, event-free survival, overall survival, and tumor microenvironment. Paired pre-/post-treatment tissues were assessed by immunofluorescence. 16 patients underwent curative resection; 1 declined surgery. Major pathological response, pathological complete response, and ypN0 were 37.5% (6/16, 95% CI 0.15–0.65), 25.0% (4/16, 95% CI 0.07–0.52), and 81.3% (13/16, 95% CI 0.54–0.96), respectively. Major pathological response was more frequent in patients with programmed death ligand 1 ≥20 (57.1%, 95%CI 0.18-0.90). Major pathological response was associated with higher pretreatment CD8⁺ T-cell density. 35.3% reported grade 3-4 adverse events. These findings suggest that neoadjuvant immunochemotherapy demonstrated favorable efficacy with a manageable safety profile in Epstein-Barr virus-associated gastric or gastroesophageal junction adenocarcinoma.</p>

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Neoadjuvant toripalimab plus CapeOX in locally advanced Epstein-Barr virus-associated gastric or gastroesophageal junction adenocarcinoma: a phase Ⅱ trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月23日

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  • Liying Zhao,
  • Hao Liu,
  • Yanfeng Hu,
  • Jiang Yu,
  • Shuqiang Yuan,
  • Fangqin Xue,
  • Kaihua Huang,
  • Xinhua Chen,
  • Tian Lin,
  • Mingli Zhao,
  • Tao Chen,
  • Lina Yu,
  • Zhao Chen,
  • Xuefeng Zhong,
  • Fengping Li,
  • Chengcai Liang,
  • Hao Chen,
  • Weihong Guo,
  • Huayuan Liang,
  • Guoxin Li

摘要

In this phase 2 trial (NCT04744649), 17 patients with locally advanced Epstein-Barr virus-associated gastric or gastroesophageal junction adenocarcinoma (cT2-4aN1-3M0) received four cycles neoadjuvant toripalimab plus capecitabine/oxaliplatin. The primary endpoint was major pathological response; secondary endpoints included pathological complete response, R0 resection, adverse events, event-free survival, overall survival, and tumor microenvironment. Paired pre-/post-treatment tissues were assessed by immunofluorescence. 16 patients underwent curative resection; 1 declined surgery. Major pathological response, pathological complete response, and ypN0 were 37.5% (6/16, 95% CI 0.15–0.65), 25.0% (4/16, 95% CI 0.07–0.52), and 81.3% (13/16, 95% CI 0.54–0.96), respectively. Major pathological response was more frequent in patients with programmed death ligand 1 ≥20 (57.1%, 95%CI 0.18-0.90). Major pathological response was associated with higher pretreatment CD8⁺ T-cell density. 35.3% reported grade 3-4 adverse events. These findings suggest that neoadjuvant immunochemotherapy demonstrated favorable efficacy with a manageable safety profile in Epstein-Barr virus-associated gastric or gastroesophageal junction adenocarcinoma.