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Title[redir]:
Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy for locally advanced rectal cancer: 3-year survival from a phase 2 study | BMC Medicine | Full Text
Description:
Neoadjuvant short-course radiotherapy (SCRT) followed by camrelizumab and chemotherapy has shown an encouraging pathological complete response rate (48.1%, primary endpoint) in patients with locally advanced rectal cancer (LARC). Here, we present the 3-year survival outcomes. In this phase 2 trial, patients with previously untreated T3-4N0M0 or T1-4N + M0 rectal adenocarcinoma received 5 × 5 Gy SCRT over 5 days, followed by two cycles of camrelizumab (200 mg) and CAPOX regimen every 3 weeks after 1 week. Total mesorectal excision (TME) was scheduled 1 week after the completion of neoadjuvant treatment. The 3-year disease-free survival (DFS) and overall survival (OS) were evaluated in this analysis. A total of 30 patients were enrolled, of whom 28 (93.3%) had microsatellite stable status (MSS) and 27 (90.0%) underwent TME. With a median follow-up of 40.8 months, the median DFS and OS were both not reached, with the 3-year DFS and OS rates of 80.2% (95% CI 58.6–91.3) and 93.3% (95% CI 75.9–98.3), respectively. Additionally, there was a trend toward improved 3-year DFS and OS in patients with pCR, postoperative pathological node-negative status (pN0), baseline negative circumferential resection margin as assessed by MRI, baseline negative extramural venous invasion and a PD-L1 combined positive score of 1 or higher, as compared with those without these characteristics. Our data support the potential efficacy of neoadjuvant SCRT followed by camrelizumab and CAPOX regimen in LARC, as indicated by 3-year survival outcomes, suggesting that this may be an alternative therapeutic strategy, especially with the potential to address an unmet need for MSS patients. www.ClinicalTrials.gov . NCT04231552.
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Keywords {🔍}
patients, pubmed, article, cancer, year, neoadjuvant, trial, rectal, google, scholar, locally, advanced, radiotherapy, survival, dfs, chemotherapy, cas, phase, immunotherapy, camrelizumab, status, scrt, chemoradiotherapy, oncol, data, versus, zhang, outcomes, pdl, study, pathological, larc, pcr, rate, results, baseline, positive, central, analysis, tao, total, tme, preoperative, emvi, bmc, shortcourse, response, received, therapy, union,
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additional information publisher' small-cell lung cancer abbreviations aes 3-year relapse-free survival 3-year disease-free survival state privacy rights methods study design pd-1/pd-l1 inhibitors pd-1/pd-l1 blockade including n-positive status locally advanced adenocarcinoma previously untreated t3-4n0m0 funding routine pd-l1 expression additional support concurrent pd-l1 blockade microsatellite instability–high deficient mismatch repair resectable lung cancer small sample size tumor mutation burden privacy choices/manage cookies rectal adenocarcinoma due low rectal disease springer nature authors scientific editing written informed consent extramural venous invasion immunotherapy-based neoadjuvant therapy pd-l1 blockade nrg-gi002 trial demonstrated information circumferential resection margin jiangsu hengrui pharmaceuticals article lin pmmr colorectal cancers pathological complete response unresectable stage iii tumor-infiltrating lymphocyte original author bmc med 23 combined positive score promising survival outcomes methods rights experienced disease recurrence 3-year survival outcomes subgroup analyses demonstrated metastatic colorectal cancer rahma oe
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headline:Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy for locally advanced rectal cancer: 3-year survival from a phase 2 study
description:Neoadjuvant short-course radiotherapy (SCRT) followed by camrelizumab and chemotherapy has shown an encouraging pathological complete response rate (48.1%, primary endpoint) in patients with locally advanced rectal cancer (LARC). Here, we present the 3-year survival outcomes. In this phase 2 trial, patients with previously untreated T3-4N0M0 or T1-4N + M0 rectal adenocarcinoma received 5 × 5 Gy SCRT over 5 days, followed by two cycles of camrelizumab (200 mg) and CAPOX regimen every 3 weeks after 1 week. Total mesorectal excision (TME) was scheduled 1 week after the completion of neoadjuvant treatment. The 3-year disease-free survival (DFS) and overall survival (OS) were evaluated in this analysis. A total of 30 patients were enrolled, of whom 28 (93.3%) had microsatellite stable status (MSS) and 27 (90.0%) underwent TME. With a median follow-up of 40.8 months, the median DFS and OS were both not reached, with the 3-year DFS and OS rates of 80.2% (95% CI 58.6–91.3) and 93.3% (95% CI 75.9–98.3), respectively. Additionally, there was a trend toward improved 3-year DFS and OS in patients with pCR, postoperative pathological node-negative status (pN0), baseline negative circumferential resection margin as assessed by MRI, baseline negative extramural venous invasion and a PD-L1 combined positive score of 1 or higher, as compared with those without these characteristics. Our data support the potential efficacy of neoadjuvant SCRT followed by camrelizumab and CAPOX regimen in LARC, as indicated by 3-year survival outcomes, suggesting that this may be an alternative therapeutic strategy, especially with the potential to address an unmet need for MSS patients.
www.ClinicalTrials.gov
. NCT04231552.
datePublished:2025-05-09T00:00:00Z
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www.ClinicalTrials.gov
. NCT04231552.
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address:
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type:PostalAddress
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address:
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type:PostalAddress
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name:Ming Cai
affiliation:
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address:
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name:Gang Li
affiliation:
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address:
name:Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
type:PostalAddress
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name:Tao Liu
affiliation:
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address:
name:Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
type:PostalAddress
type:Organization
name:Huazhong University of Science and Technology
address:
name:Department of Digestive Surgical Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
type:PostalAddress
type:Organization
name:Kailin Cai
affiliation:
name:Huazhong University of Science and Technology
address:
name:Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
type:PostalAddress
type:Organization
name:Jing Wang
affiliation:
name:Huazhong University of Science and Technology
address:
name:Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
type:PostalAddress
type:Organization
name:Junli Liu
affiliation:
name:Huazhong University of Science and Technology
address:
name:Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
type:PostalAddress
type:Organization
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affiliation:
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address:
name:Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
type:PostalAddress
type:Organization
name:Weikang Zhang
affiliation:
name:Huazhong University of Science and Technology
address:
name:Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
type:PostalAddress
type:Organization
name:Jinbo Gao
affiliation:
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address:
name:Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
type:PostalAddress
type:Organization
name:Chuanqing Wu
affiliation:
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address:
name:Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
type:PostalAddress
type:Organization
name:Linfang Wang
affiliation:
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address:
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type:PostalAddress
type:Organization
name:Zheng Wang
affiliation:
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address:
name:Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
type:PostalAddress
type:Organization
name:Zhiguo Hou
affiliation:
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address:
name:Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China
type:PostalAddress
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name:Hongyi Kou
affiliation:
name:Jiangsu Hengrui Pharmaceuticals Co., Ltd.
address:
name:Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China
type:PostalAddress
type:Organization
name:Kaixiong Tao
affiliation:
name:Huazhong University of Science and Technology
address:
name:Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
type:PostalAddress
type:Organization
email:[email protected]
name:Tao Zhang
affiliation:
name:Huazhong University of Science and Technology
address:
name:Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
type:PostalAddress
type:Organization
name:Hubei Key Laboratory of Precision Radiation Oncology
address:
name:Hubei Key Laboratory of Precision Radiation Oncology, Wuhan, China
type:PostalAddress
type:Organization
name:Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
address:
name:Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
type:PostalAddress
type:Organization
email:[email protected]
PostalAddress:
name:Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name:Hubei Key Laboratory of Precision Radiation Oncology, Wuhan, China
name:Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name:Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name:Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name:Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name:Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name:Department of Digestive Surgical Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name:Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name:Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name:Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name:Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name:Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name:Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name:Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name:Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name:Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name:Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China
name:Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China
name:Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name:Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name:Hubei Key Laboratory of Precision Radiation Oncology, Wuhan, China
name:Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
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