Combining chemotherapy and tislelizumab with preoperative split-course hypofraction radiotherapy for locally advanced rectal cancer: study protocol of a prospective, single-arm, phase II trial
Introduction Short-course radiotherapy (SCRT) with systemic therapy has the potential to further improve the long-term efficacy in patients with locally advanced rectal cancer (LARC). To maximise the benefits of neoadjuvant therapy for improved prognosis, it is important to determine the optimal mix...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/3/e066976.full |
| _version_ | 1797745143005052928 |
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| author | Pan Chi Rong Zheng Zhihua Li Benhua Xu Bi-Si Wang |
| author_facet | Pan Chi Rong Zheng Zhihua Li Benhua Xu Bi-Si Wang |
| author_sort | Pan Chi |
| collection | DOAJ |
| description | Introduction Short-course radiotherapy (SCRT) with systemic therapy has the potential to further improve the long-term efficacy in patients with locally advanced rectal cancer (LARC). To maximise the benefits of neoadjuvant therapy for improved prognosis, it is important to determine the optimal mix of chemotherapy, immunotherapy and SCRT.Methods and analysis Fifty treatment-naïve patients with operable LARC (T3–4 and/or N+) will be recruited. Patients will be synchronously treated with capecitabine plus oxaliplatin (CAPOX) chemotherapy, tislelizumab and preoperative split-course hypofraction radiotherapy (SCHR) (5×7 Gy) before surgery. Chemotherapy for CAPOX starts on day 1 of every 21-day cycle: on day 1, oxaliplatin 130 mg/m2 will be injected intravenously. On days 1–14, capecitabine 1000 mg/m2 was ingested two times a day. Simultaneously, tocilizumab 200 mg will be given intravenously on the first day of every 21-day cycle. A single 7 Gy SCHR treatment (day 7 of each 21-day cycle) will be delivered five times during the seventh day of treatment. The primary endpoint will be pathological complete response. The secondary outcomes will be the 3-year disease-free survival, local recurrence rate, overall survival, sphincter-sparing surgery rate, R0 resection rate, predictive biomarkers and quality of life.Ethics and dissemination The study protocol was approved by the Ethics Committee of Xiehe Affiliated Hospital of Fujian Medical University (XAHFMU) (No. 2021YF025-01). Results from our study will be disseminated in international peer-reviewed journals. All study procedures were developed in order to assure data protection and confidentiality.Trial registration number NCT05176964. |
| first_indexed | 2024-03-12T15:19:15Z |
| format | Article |
| id | doaj.art-c09a2ef33aa34203a8935a3cd4ac20ed |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-12T15:19:15Z |
| publishDate | 2023-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-c09a2ef33aa34203a8935a3cd4ac20ed2023-08-11T07:20:07ZengBMJ Publishing GroupBMJ Open2044-60552023-03-0113310.1136/bmjopen-2022-066976Combining chemotherapy and tislelizumab with preoperative split-course hypofraction radiotherapy for locally advanced rectal cancer: study protocol of a prospective, single-arm, phase II trialPan Chi0Rong Zheng1Zhihua Li2Benhua Xu3Bi-Si Wang4Department of Colorectal Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, People`s Republic of ChinaDepartment of Radiation Oncology, Fujian Medical University Union Hospital, Fuzhou, Fujian, People`s Republic of ChinaDepartment of Oncology, The Second Hospital of Zhangzhou, Zhangzhou, People`s Republic of ChinaDepartment of Radiation Oncology, Fujian Medical University Union Hospital, Fuzhou, Fujian, People`s Republic of ChinaDepartment of Radiation Oncology, Fujian Medical University Union Hospital, Fuzhou, Fujian, People`s Republic of ChinaIntroduction Short-course radiotherapy (SCRT) with systemic therapy has the potential to further improve the long-term efficacy in patients with locally advanced rectal cancer (LARC). To maximise the benefits of neoadjuvant therapy for improved prognosis, it is important to determine the optimal mix of chemotherapy, immunotherapy and SCRT.Methods and analysis Fifty treatment-naïve patients with operable LARC (T3–4 and/or N+) will be recruited. Patients will be synchronously treated with capecitabine plus oxaliplatin (CAPOX) chemotherapy, tislelizumab and preoperative split-course hypofraction radiotherapy (SCHR) (5×7 Gy) before surgery. Chemotherapy for CAPOX starts on day 1 of every 21-day cycle: on day 1, oxaliplatin 130 mg/m2 will be injected intravenously. On days 1–14, capecitabine 1000 mg/m2 was ingested two times a day. Simultaneously, tocilizumab 200 mg will be given intravenously on the first day of every 21-day cycle. A single 7 Gy SCHR treatment (day 7 of each 21-day cycle) will be delivered five times during the seventh day of treatment. The primary endpoint will be pathological complete response. The secondary outcomes will be the 3-year disease-free survival, local recurrence rate, overall survival, sphincter-sparing surgery rate, R0 resection rate, predictive biomarkers and quality of life.Ethics and dissemination The study protocol was approved by the Ethics Committee of Xiehe Affiliated Hospital of Fujian Medical University (XAHFMU) (No. 2021YF025-01). Results from our study will be disseminated in international peer-reviewed journals. All study procedures were developed in order to assure data protection and confidentiality.Trial registration number NCT05176964.https://bmjopen.bmj.com/content/13/3/e066976.full |
| spellingShingle | Pan Chi Rong Zheng Zhihua Li Benhua Xu Bi-Si Wang Combining chemotherapy and tislelizumab with preoperative split-course hypofraction radiotherapy for locally advanced rectal cancer: study protocol of a prospective, single-arm, phase II trial BMJ Open |
| title | Combining chemotherapy and tislelizumab with preoperative split-course hypofraction radiotherapy for locally advanced rectal cancer: study protocol of a prospective, single-arm, phase II trial |
| title_full | Combining chemotherapy and tislelizumab with preoperative split-course hypofraction radiotherapy for locally advanced rectal cancer: study protocol of a prospective, single-arm, phase II trial |
| title_fullStr | Combining chemotherapy and tislelizumab with preoperative split-course hypofraction radiotherapy for locally advanced rectal cancer: study protocol of a prospective, single-arm, phase II trial |
| title_full_unstemmed | Combining chemotherapy and tislelizumab with preoperative split-course hypofraction radiotherapy for locally advanced rectal cancer: study protocol of a prospective, single-arm, phase II trial |
| title_short | Combining chemotherapy and tislelizumab with preoperative split-course hypofraction radiotherapy for locally advanced rectal cancer: study protocol of a prospective, single-arm, phase II trial |
| title_sort | combining chemotherapy and tislelizumab with preoperative split course hypofraction radiotherapy for locally advanced rectal cancer study protocol of a prospective single arm phase ii trial |
| url | https://bmjopen.bmj.com/content/13/3/e066976.full |
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