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
Abstract 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...
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| Format: | Article |
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Wiley
2024-02-01
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| Series: | Cancer Medicine |
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| Online Access: | https://doi.org/10.1002/cam4.7006 |
| _version_ | 1797216942497464320 |
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| author | Wen‐Jin Zhong Jian‐An Lin Chu‐Ying Wu Jian‐Tian Wang Jun‐Xing Chen Hui‐Da Zheng Kai Ye |
| author_facet | Wen‐Jin Zhong Jian‐An Lin Chu‐Ying Wu Jian‐Tian Wang Jun‐Xing Chen Hui‐Da Zheng Kai Ye |
| author_sort | Wen‐Jin Zhong |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-03-07T15:43:09Z |
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| issn | 2045-7634 |
| language | English |
| last_indexed | 2024-04-24T11:53:59Z |
| publishDate | 2024-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj.art-0455105b92a3418cb49c520f61baaa6b2024-04-09T05:45:47ZengWileyCancer Medicine2045-76342024-02-01133n/an/a10.1002/cam4.7006Efficacy 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 studyWen‐Jin Zhong0Jian‐An Lin1Chu‐Ying Wu2Jian‐Tian Wang3Jun‐Xing Chen4Hui‐Da Zheng5Kai Ye6Department of Gastrointestinal Surgery The Second Affiliated Hospital of Fujian Medical University QuanZhou City Fujian ChinaDepartment of Gastrointestinal Surgery The Second Affiliated Hospital of Fujian Medical University QuanZhou City Fujian ChinaDepartment of Gastrointestinal Surgery The Second Affiliated Hospital of Fujian Medical University QuanZhou City Fujian ChinaDepartment of Gastrointestinal Surgery The Second Affiliated Hospital of Fujian Medical University QuanZhou City Fujian ChinaDepartment of Gastrointestinal Surgery The Second Affiliated Hospital of Fujian Medical University QuanZhou City Fujian ChinaDepartment of Gastrointestinal Surgery The Second Affiliated Hospital of Fujian Medical University QuanZhou City Fujian ChinaDepartment of Gastrointestinal Surgery The Second Affiliated Hospital of Fujian Medical University QuanZhou City Fujian ChinaAbstract 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.https://doi.org/10.1002/cam4.7006Camrelizumabgastric cancergastroesophageal junction cancerimmune checkpoint inhibitorNeoadjuvant therapyS‐1 |
| spellingShingle | Wen‐Jin Zhong Jian‐An Lin Chu‐Ying Wu Jian‐Tian Wang Jun‐Xing Chen Hui‐Da Zheng Kai Ye 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 Cancer Medicine Camrelizumab gastric cancer gastroesophageal junction cancer immune checkpoint inhibitor Neoadjuvant therapy S‐1 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Camrelizumab gastric cancer gastroesophageal junction cancer immune checkpoint inhibitor Neoadjuvant therapy S‐1 |
| url | https://doi.org/10.1002/cam4.7006 |
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