Neoadjuvant adebrelimab combined with chemotherapy (cisplatin/carboplatin and etoposide) for limited-stage small-cell lung cancer: a study protocol of phase 2 trial (NIUS)
Introduction Small-cell lung cancer (SCLC) is a highly malignant neuroendocrine tumour, and concurrent chemoradiotherapy is the current recommended treatment for limited-stage SCLC. However, the overall survival (OS) of patients with SCLC remains poor. Therefore, improving the survival of patients w...
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BMJ Publishing Group
2025-01-01
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| author | Yan Zhang Qian Huang Mengxia Li Xi Zheng Yanyang Liu Long Tian Guizhi Chen Hongyu Xu Daxing Zhu |
| author_facet | Yan Zhang Qian Huang Mengxia Li Xi Zheng Yanyang Liu Long Tian Guizhi Chen Hongyu Xu Daxing Zhu |
| author_sort | Yan Zhang |
| collection | DOAJ |
| description | Introduction Small-cell lung cancer (SCLC) is a highly malignant neuroendocrine tumour, and concurrent chemoradiotherapy is the current recommended treatment for limited-stage SCLC. However, the overall survival (OS) of patients with SCLC remains poor. Therefore, improving the survival of patients with SCLC and benefitting more patients are urgent clinical requirements. Immunotherapy has achieved good efficacy in extensive-stage SCLC and non-SCLC. However, the use of neoadjuvant immunotherapy in limited-stage SCLC is unknown but promising. To this end, we plan to conduct a study on adebrelimab in combination with chemotherapy for the neoadjuvant treatment of limited-stage SCLC.Methods and analysis This will be a single-arm, prospective study. The primary endpoint of this study will be a pathological complete remission rate. The secondary endpoints will be a major pathological response, objective response rate, event-free survival, OS, R0 resection rate, safety and potential predictive biomarker parameters related to efficacy in peripheral blood samples, including minimal residual disease, circulating tumour cells and cluster of differentiation (CD) 4/CD8. This study will enrol 28 patients.Ethics and dissemination This study was approved by the Biomedical Ethics Review Committee of West China Hospital, Sichuan University, on 1 August 2023 (grant number 2023[987]). The version of this study protocol is V7.0. The patients have been enrolled since September 2023. This study will conclude in January 2026, and the results will be presented to peer-reviewed medical journals and international scientific conferences in 2027. This study will provide important data on whether neoadjuvant treatment with adebrelimab combined with chemotherapy is clinically beneficial in patients with limited-stage SCLC.(Prospective study of neoadjuvant adebrelimab combined with chemotherapy in limited-stage SCLC; Chinese Clinical Trial Registry (ChiCTR), www.chictr.org.cn/; Number, ChiCTR2300074591.)Trial registration number ChiCTR2300074591 |
| format | Article |
| id | doaj-art-92c076c823964d07a56699c439e43530 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-92c076c823964d07a56699c439e435302025-01-15T01:50:09ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-087302Neoadjuvant adebrelimab combined with chemotherapy (cisplatin/carboplatin and etoposide) for limited-stage small-cell lung cancer: a study protocol of phase 2 trial (NIUS)Yan Zhang0Qian Huang1Mengxia Li2Xi Zheng3Yanyang Liu4Long Tian5Guizhi Chen6Hongyu Xu7Daxing Zhu8Department of Medical Oncology, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaCenter for Rural Health Research, College of Public Health, East Tennessee State University, Johnson City, TN, USAJiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, ChinaPeking-Tsinghua Center for Life Sciences, Peking University, Beijing, ChinaDepartment of Medical Oncology, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaLung Cancer Center/Lung Cancer Institute, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaLung Cancer Center/Lung Cancer Institute, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaDepartment of Oncology, No 363 Hospital, Chengdu, Sichuan, ChinaLung Cancer Center/Lung Cancer Institute, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaIntroduction Small-cell lung cancer (SCLC) is a highly malignant neuroendocrine tumour, and concurrent chemoradiotherapy is the current recommended treatment for limited-stage SCLC. However, the overall survival (OS) of patients with SCLC remains poor. Therefore, improving the survival of patients with SCLC and benefitting more patients are urgent clinical requirements. Immunotherapy has achieved good efficacy in extensive-stage SCLC and non-SCLC. However, the use of neoadjuvant immunotherapy in limited-stage SCLC is unknown but promising. To this end, we plan to conduct a study on adebrelimab in combination with chemotherapy for the neoadjuvant treatment of limited-stage SCLC.Methods and analysis This will be a single-arm, prospective study. The primary endpoint of this study will be a pathological complete remission rate. The secondary endpoints will be a major pathological response, objective response rate, event-free survival, OS, R0 resection rate, safety and potential predictive biomarker parameters related to efficacy in peripheral blood samples, including minimal residual disease, circulating tumour cells and cluster of differentiation (CD) 4/CD8. This study will enrol 28 patients.Ethics and dissemination This study was approved by the Biomedical Ethics Review Committee of West China Hospital, Sichuan University, on 1 August 2023 (grant number 2023[987]). The version of this study protocol is V7.0. The patients have been enrolled since September 2023. This study will conclude in January 2026, and the results will be presented to peer-reviewed medical journals and international scientific conferences in 2027. This study will provide important data on whether neoadjuvant treatment with adebrelimab combined with chemotherapy is clinically beneficial in patients with limited-stage SCLC.(Prospective study of neoadjuvant adebrelimab combined with chemotherapy in limited-stage SCLC; Chinese Clinical Trial Registry (ChiCTR), www.chictr.org.cn/; Number, ChiCTR2300074591.)Trial registration number ChiCTR2300074591https://bmjopen.bmj.com/content/15/1/e087302.full |
| spellingShingle | Yan Zhang Qian Huang Mengxia Li Xi Zheng Yanyang Liu Long Tian Guizhi Chen Hongyu Xu Daxing Zhu Neoadjuvant adebrelimab combined with chemotherapy (cisplatin/carboplatin and etoposide) for limited-stage small-cell lung cancer: a study protocol of phase 2 trial (NIUS) BMJ Open |
| title | Neoadjuvant adebrelimab combined with chemotherapy (cisplatin/carboplatin and etoposide) for limited-stage small-cell lung cancer: a study protocol of phase 2 trial (NIUS) |
| title_full | Neoadjuvant adebrelimab combined with chemotherapy (cisplatin/carboplatin and etoposide) for limited-stage small-cell lung cancer: a study protocol of phase 2 trial (NIUS) |
| title_fullStr | Neoadjuvant adebrelimab combined with chemotherapy (cisplatin/carboplatin and etoposide) for limited-stage small-cell lung cancer: a study protocol of phase 2 trial (NIUS) |
| title_full_unstemmed | Neoadjuvant adebrelimab combined with chemotherapy (cisplatin/carboplatin and etoposide) for limited-stage small-cell lung cancer: a study protocol of phase 2 trial (NIUS) |
| title_short | Neoadjuvant adebrelimab combined with chemotherapy (cisplatin/carboplatin and etoposide) for limited-stage small-cell lung cancer: a study protocol of phase 2 trial (NIUS) |
| title_sort | neoadjuvant adebrelimab combined with chemotherapy cisplatin carboplatin and etoposide for limited stage small cell lung cancer a study protocol of phase 2 trial nius |
| url | https://bmjopen.bmj.com/content/15/1/e087302.full |
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