Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy for locally advanced rectal cancer: 3-year survival from a phase 2 study.
Zhenyu Lin, Peng Zhang, Ming Cai, Gang Li, Tao Liu, Kailin Cai, Jing Wang, Junli Liu, Hongli Liu, Weikang Zhang, Jinbo Gao, Chuanqing Wu, Linfang Wang, Zheng Wang, Zhiguo Hou, Hongyi Kou, Kaixiong Tao, Tao Zhang
{"title":"Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy for locally advanced rectal cancer: 3-year survival from a phase 2 study.","authors":"Zhenyu Lin, Peng Zhang, Ming Cai, Gang Li, Tao Liu, Kailin Cai, Jing Wang, Junli Liu, Hongli Liu, Weikang Zhang, Jinbo Gao, Chuanqing Wu, Linfang Wang, Zheng Wang, Zhiguo Hou, Hongyi Kou, Kaixiong Tao, Tao Zhang","doi":"10.1186/s12916-025-04087-x","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>www.</p><p><strong>Clinicaltrials: </strong>gov . NCT04231552.</p>","PeriodicalId":9188,"journal":{"name":"BMC Medicine","volume":"23 1","pages":"273"},"PeriodicalIF":7.0000,"publicationDate":"2025-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12065332/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12916-025-04087-x","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
Abstract
Background: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
期刊介绍：
BMC Medicine is an open access, transparent peer-reviewed general medical journal. It is the flagship journal of the BMC series and publishes outstanding and influential research in various areas including clinical practice, translational medicine, medical and health advances, public health, global health, policy, and general topics of interest to the biomedical and sociomedical professional communities. In addition to research articles, the journal also publishes stimulating debates, reviews, unique forum articles, and concise tutorials. All articles published in BMC Medicine are included in various databases such as Biological Abstracts, BIOSIS, CAS, Citebase, Current contents, DOAJ, Embase, MEDLINE, PubMed, Science Citation Index Expanded, OAIster, SCImago, Scopus, SOCOLAR, and Zetoc.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
