Phase II study of perioperative camrelizumab and XELOX for locally advanced gastric or gastroesophageal junction adenocarcinoma

• DOI: 10.1111/cas.16425
• Publication Date: 2024-12-10T17:58:56Z
• Authors: Jiaxing He; Bo Zhang; Shuai Zhou; Ying Yang; Zhuo Han; Tao Wu; Qing Qiao; Haicheng Yang; Xianli He; Nan Wang
• Keywords: Neoadjuvant Therapy; Clinical endpoint

Abstract Immune checkpoint inhibitors combined with chemotherapy have shown promising efficacy in treating gastric or gastroesophageal junction (G/GEJ) adenocarcinoma the neoadjuvant setting. This phase II trial (NCT05715632) aimed to investigate and safety of perioperative camrelizumab plus XELOX patients locally advanced G/GEJ adenocarcinoma. Treatment‐naive cT3‐4aN1‐3 M0 resectable were recruited receive (200 mg, intravenously) on Day 1 (oxaliplatin at 130 mg/m 2 capecitabine 1000 Days 1–14) every 3 weeks for four cycles, followed by surgery adjuvant cycles. The primary endpoint was pathological complete response (pCR; ypT0N0) rate. From September 2020 January 2023, 46 enrolled, all completed therapy. Among them, 43 underwent D2 resection. In intention‐to‐treat population, pCR achieved nine (19.6%, 95% confidence interval [CI]: 9.9%–34.4%), major 25 (54.3%, CI: 39.2%–68.8%). objective rate 69.6%, which 12 a 20 partial response. 1‐year event‐free survival disease‐free rates both 93.1%. Treatment‐related adverse events (TRAEs) occurred 42 (91.3%) patients, grade TRAEs (19.6%) patients. No grades 4–5 observed. Perioperative showed an acceptable profile