PMID- 38400680 OWN - NLM STAT- MEDLINE DCOM- 20240226 LR - 20240227 IS - 2045-7634 (Electronic) IS - 2045-7634 (Linking) VI - 13 IP - 3 DP - 2024 Feb TI - Efficacy and safety of camrelizumab combined with oxaliplatin and S-1 as neoadjuvant treatment in locally advanced gastric or gastroesophageal junction cancer: A phase II, single-arm study. PG - e7006 LID - 10.1002/cam4.7006 [doi] LID - e7006 AB - PURPOSE: In the present study, we aimed to evaluate the efficacy and safety of camrelizumab combined with oxaliplatin plus S-1 in patients with resectable gastric or gastroesophageal junction cancer. METHODS: In this single-arm, phase II clinical trial, patients with locally advanced gastric or gastroesophageal junction adenocarcinoma were enrolled to receive three cycles of neoadjuvant camrelizumab and oxaliplatin plus S-1 every 3 weeks, followed by surgical resection and adjuvant therapy with the same regimen. The primary endpoint was pathological complete response (pCR) (ypT0) rate and secondary endpoints were R0 resection rate, total pCR (tpCR, ypT0N0) rate, major pathological response (MPR) rate, downstaging, objective response rate (ORR), disease control rate (DCR), event-free survival (EFS), overall survival (OS), and safety. RESULTS: Between September, 2020 and January, 2022, a total of 29 patients were enrolled in the present study, all of whom completed neoadjuvant therapy and underwent surgery. Three (10.3%) (95% CI: 2.2-27.4) patients achieved pCR as well as tpCR, 20 (69.0%) patients had MPR and 28 (96.6%) patients achieved R0 resection. Treatment-emergent adverse events (AEs) of any grade were observed in 24 (82.8%) patients. Immune-related adverse events of any grade were reported in 13 (44.8%) patients, whereas no grade 3 or higher adverse events occurred. CONCLUSION: The neoadjuvant therapy with camrelizumab in combination with oxaliplatin and S-1 showed a modest pCR rate, and favorable MPR rate and safety profile in patients with gastric or gastroesophageal junction cancer. CI - (c) 2024 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. FAU - Zhong, Wen-Jin AU - Zhong WJ AD - Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Fujian Medical University, QuanZhou City, Fujian, China. FAU - Lin, Jian-An AU - Lin JA AD - Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Fujian Medical University, QuanZhou City, Fujian, China. FAU - Wu, Chu-Ying AU - Wu CY AD - Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Fujian Medical University, QuanZhou City, Fujian, China. FAU - Wang, Jiantian AU - Wang J AD - Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Fujian Medical University, QuanZhou City, Fujian, China. FAU - Chen, Jun-Xing AU - Chen JX AD - Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Fujian Medical University, QuanZhou City, Fujian, China. FAU - Zheng, Huida AU - Zheng H AD - Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Fujian Medical University, QuanZhou City, Fujian, China. FAU - Ye, Kai AU - Ye K AUID- ORCID: 0000-0001-8567-6197 AD - Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Fujian Medical University, QuanZhou City, Fujian, China. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PL - United States TA - Cancer Med JT - Cancer medicine JID - 101595310 RN - 04ZR38536J (Oxaliplatin) RN - 73096E137E (camrelizumab) RN - 0 (Antibodies, Monoclonal, Humanized) SB - IM MH - Humans MH - *Neoadjuvant Therapy MH - Oxaliplatin MH - Esophagogastric Junction MH - *Stomach Neoplasms/drug therapy MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects MH - *Antibodies, Monoclonal, Humanized PMC - PMC10891470 OTO - NOTNLM OT - Camrelizumab OT - Neoadjuvant therapy OT - S-1 OT - gastric cancer OT - gastroesophageal junction cancer OT - immune checkpoint inhibitor COIS- The authors declare no conflict of interests. EDAT- 2024/02/24 11:46 MHDA- 2024/02/26 06:45 PMCR- 2024/02/24 CRDT- 2024/02/24 04:23 PHST- 2023/11/02 00:00 [revised] PHST- 2023/07/25 00:00 [received] PHST- 2024/01/31 00:00 [accepted] PHST- 2024/02/26 06:45 [medline] PHST- 2024/02/24 11:46 [pubmed] PHST- 2024/02/24 04:23 [entrez] PHST- 2024/02/24 00:00 [pmc-release] AID - CAM47006 [pii] AID - 10.1002/cam4.7006 [doi] PST - ppublish SO - Cancer Med. 2024 Feb;13(3):e7006. doi: 10.1002/cam4.7006.