Neoadjuvant sintilimab and chemotherapy for resectable esophageal squamous cell carcinoma: a phase II clinical trial
BackgroundCombination of anti-PD-1 monoclonal antibody with chemotherapy has been widely used as a first-line treatment for metastatic esophageal squamous cell carcinoma (ESCC). However, the efficacy of this therapeutic combination as a neoadjuvant intervention for resectable ESCC remains inadequate...
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Frontiers Media S.A.
2025-04-01
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| Series: | Frontiers in Immunology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fimmu.2025.1486275/full |
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| author | Jincheng Guo Chengrui Qiao Jiabin Lu Shiqing Yang Boyi Zhang Dongxia Tang Hui Pang |
| author_facet | Jincheng Guo Chengrui Qiao Jiabin Lu Shiqing Yang Boyi Zhang Dongxia Tang Hui Pang |
| author_sort | Jincheng Guo |
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| description | BackgroundCombination of anti-PD-1 monoclonal antibody with chemotherapy has been widely used as a first-line treatment for metastatic esophageal squamous cell carcinoma (ESCC). However, the efficacy of this therapeutic combination as a neoadjuvant intervention for resectable ESCC remains inadequately explored. This study aims to evaluate the efficacy and safety of sintilimab in combination with chemotherapy as a neoadjuvant therapy for ESCC.MethodsIn this single-arm, phase II study, patients with histopathologically diagnosed resectable ESCC who had clinical cT1-3/N0-1M0 (stage II-III) were recruited. Sintilimab (200mg, iv, d1) in combined with chemotherapy (nab-paclitaxel 260 mg/m2, d1 and cisplatin 75 mg/m2, d1-3) were administered every 3 weeks for 2 cycles. The primary endpoint was pathological complete response (pCR).ResultsFrom November 2020 through November 2022, 29 patients were enrolled and 27 completed the two cycles of neoadjuvant therapy. A total of 21 patients underwent surgery. The pCR rate was 28.6% (6/21) and the major pathologic response (MPR) rate was 42.9% (9/21). The most common Grade 3 or 4 treatment-related adverse events were leukopenia (26.7%) and neutropenia (20%). No delays in surgical procedures or unexpected surgical complications attributable to the treatment were reported.ConclusionsThe combination of sintilimab and chemotherapy as a neoadjuvant regimen was tolerable and associated with favorable responses for ESCC patients. Given these favorable results, this regimen could serve as a viable alternative in the neoadjuvant treatment landscape for ESCC, with particular applicability to Chinese patient populations.Clinical trial registrationhttps://www.chictr.org.cn/, identifier ChiCTR2000040345. |
| format | Article |
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| issn | 1664-3224 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Immunology |
| spelling | doaj-art-bc27ecdc617c465b9a783f41ddf2ee3c2025-08-20T01:54:16ZengFrontiers Media S.A.Frontiers in Immunology1664-32242025-04-011610.3389/fimmu.2025.14862751486275Neoadjuvant sintilimab and chemotherapy for resectable esophageal squamous cell carcinoma: a phase II clinical trialJincheng Guo0Chengrui Qiao1Jiabin Lu2Shiqing Yang3Boyi Zhang4Dongxia Tang5Hui Pang6Department of Thoracic Surgery, The First Affiliated Hospital of Henan Polytechnic University, Jiaozuo, Henan, ChinaDepartment of Thoracic Surgery, The First Affiliated Hospital of Henan Polytechnic University, Jiaozuo, Henan, ChinaDepartment of Thoracic Surgery, The First Affiliated Hospital of Henan Polytechnic University, Jiaozuo, Henan, ChinaDepartment of Thoracic Surgery, The First Affiliated Hospital of Henan Polytechnic University, Jiaozuo, Henan, ChinaDepartment of Thoracic Surgery, The First Affiliated Hospital of Henan Polytechnic University, Jiaozuo, Henan, ChinaDepartment of Medical Oncology, The First Affiliated Hospital of Henan Polytechnic University, Jiaozuo, Henan, ChinaDepartment of Medical Oncology, The First Affiliated Hospital of Henan Polytechnic University, Jiaozuo, Henan, ChinaBackgroundCombination of anti-PD-1 monoclonal antibody with chemotherapy has been widely used as a first-line treatment for metastatic esophageal squamous cell carcinoma (ESCC). However, the efficacy of this therapeutic combination as a neoadjuvant intervention for resectable ESCC remains inadequately explored. This study aims to evaluate the efficacy and safety of sintilimab in combination with chemotherapy as a neoadjuvant therapy for ESCC.MethodsIn this single-arm, phase II study, patients with histopathologically diagnosed resectable ESCC who had clinical cT1-3/N0-1M0 (stage II-III) were recruited. Sintilimab (200mg, iv, d1) in combined with chemotherapy (nab-paclitaxel 260 mg/m2, d1 and cisplatin 75 mg/m2, d1-3) were administered every 3 weeks for 2 cycles. The primary endpoint was pathological complete response (pCR).ResultsFrom November 2020 through November 2022, 29 patients were enrolled and 27 completed the two cycles of neoadjuvant therapy. A total of 21 patients underwent surgery. The pCR rate was 28.6% (6/21) and the major pathologic response (MPR) rate was 42.9% (9/21). The most common Grade 3 or 4 treatment-related adverse events were leukopenia (26.7%) and neutropenia (20%). No delays in surgical procedures or unexpected surgical complications attributable to the treatment were reported.ConclusionsThe combination of sintilimab and chemotherapy as a neoadjuvant regimen was tolerable and associated with favorable responses for ESCC patients. Given these favorable results, this regimen could serve as a viable alternative in the neoadjuvant treatment landscape for ESCC, with particular applicability to Chinese patient populations.Clinical trial registrationhttps://www.chictr.org.cn/, identifier ChiCTR2000040345.https://www.frontiersin.org/articles/10.3389/fimmu.2025.1486275/fullesophageal squamous cell carcinomaneoadjuvant therapysintilimabchemotherapyimmunotherapy |
| spellingShingle | Jincheng Guo Chengrui Qiao Jiabin Lu Shiqing Yang Boyi Zhang Dongxia Tang Hui Pang Neoadjuvant sintilimab and chemotherapy for resectable esophageal squamous cell carcinoma: a phase II clinical trial Frontiers in Immunology esophageal squamous cell carcinoma neoadjuvant therapy sintilimab chemotherapy immunotherapy |
| title | Neoadjuvant sintilimab and chemotherapy for resectable esophageal squamous cell carcinoma: a phase II clinical trial |
| title_full | Neoadjuvant sintilimab and chemotherapy for resectable esophageal squamous cell carcinoma: a phase II clinical trial |
| title_fullStr | Neoadjuvant sintilimab and chemotherapy for resectable esophageal squamous cell carcinoma: a phase II clinical trial |
| title_full_unstemmed | Neoadjuvant sintilimab and chemotherapy for resectable esophageal squamous cell carcinoma: a phase II clinical trial |
| title_short | Neoadjuvant sintilimab and chemotherapy for resectable esophageal squamous cell carcinoma: a phase II clinical trial |
| title_sort | neoadjuvant sintilimab and chemotherapy for resectable esophageal squamous cell carcinoma a phase ii clinical trial |
| topic | esophageal squamous cell carcinoma neoadjuvant therapy sintilimab chemotherapy immunotherapy |
| url | https://www.frontiersin.org/articles/10.3389/fimmu.2025.1486275/full |
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