{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T14:02:55Z","timestamp":1790949775546,"version":"4.1.0"},"reference-count":32,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2024,7,17]],"date-time":"2024-07-17T00:00:00Z","timestamp":1721174400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82073352"],"award-info":[{"award-number":["82073352"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Colorectal Disease"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>For patients with locally advanced rectal cancer, previous STELLAR studies have shown that a new adjuvant treatment paradigm of short\u2010course radiotherapy followed by neoadjuvant chemotherapy can achieve pathological complete response rates superior to those of standard care; however, the 3\u2010year DFS is inferior to neoadjuvant concurrent radiotherapy. Recent studies have shown that immune checkpoint inhibitors may improve the prognosis of rectal cancer and have good synergy with radiotherapy. Therefore, neoadjuvant chemotherapy combined with immune checkpoint inhibitors after a short course of radiotherapy has the potential to further improve complete response rates and prognosis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>The STELLAR II study is a multicentre, open label, two\u2010arm randomized, phase II\/III trial of short\u2010course radiotherapy followed by neoadjuvant chemotherapy concurrent with immunotherapy for locally advanced rectal cancer. A total of 588 patients with locally advanced rectal cancer (LARC) will be randomly assigned to the experimental and control groups. The experimental group will receive short\u2010course radiotherapy and neoadjuvant chemotherapy in combination with sindilizumab, while the control group will receive short\u2010course radiotherapy and neoadjuvant chemotherapy. Both groups will subsequently receive either total rectal mesenteric resection or a watch &amp; wait (W&amp;W) strategy. The phase II primary endpoint is the complete remission rate, and the secondary endpoints include grade 3\u20134 adverse events, perioperative complications, R0 resection rate, overall survival, local recurrence rate, distant metastasis rate and quality of life score. A seamless phase II\/III randomized controlled design will be used to investigate the effectiveness and safety of the TNT strategy with the addition of immunotherapy. The trial opened, and the first patient was recruited on 31 August 2022. Trial registration number and date of registration: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link> <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"NCBI:refseq\" xlink:href=\"NCT05484024\">NCT05484024<\/jats:ext-link>, 29 July 2022.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>The STELLAR II trial will prospectively evaluate the efficacy of TNT treatment strategies that incorporate immune checkpoint inhibitors. The trial will yield important information to guide routine management of patients with local advanced rectal cancer.<\/jats:p><\/jats:sec>","DOI":"10.1111\/codi.17090","type":"journal-article","created":{"date-parts":[[2024,7,18]],"date-time":"2024-07-18T04:33:51Z","timestamp":1721277231000},"page":"1732-1740","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Preoperative short\u2010course radiotherapy followed by chemotherapy and PD\u20101 inhibitor administration for locally advanced rectal cancer: A study protocol of a randomized phase II\/III trial (STELLAR II study)"],"prefix":"10.1111","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5515-0124","authenticated-orcid":false,"given":"Wenjue","family":"Zhang","sequence":"first","affiliation":[{"name":"Department of Radiation Oncology, National Cancer Center\/National Clinical Research Centre for Cancer\/Cancer Hospital &amp; Shenzhen Hospital Chinese Academy of Medical Sciences and Peking Union Medical College  Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuan","family":"Tang","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Molecular Oncology, Department of Radiation Oncology, National Cancer Center\/National Clinical Research Centre for Cancer\/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lichun","family":"Wei","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Xijing Hospital Air Force Medical University  Xi'an China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shixin","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology Jilin Provincial Cancer Hospital  Changchun China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenling","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Oncology Affiliated Hospital of Guizhou Medical University  Guiyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yihebali","family":"Chi","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Molecular Oncology, Department of Medical Oncology, National Cancer Centre\/National Clinical Research Centre for Cancer\/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, National Cancer Centre\/National Clinical Research Centre for Cancer\/Cancer Hospital &amp; Shenzhen Hospital Chinese Academy of Medical Sciences and Peking Union Medical College  Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenyan","family":"Kang","sequence":"additional","affiliation":[{"name":"Department of Radiology, National Cancer Centre\/National Clinical Research Centre for Cancer\/Cancer Hospital &amp; Shenzhen Hospital Chinese Academy of Medical Sciences and Peking Union Medical College  Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenting","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Pathology, National Cancer Centre\/National Clinical Research Centre for Cancer\/Cancer Hospital &amp; Shenzhen Hospital Chinese Academy of Medical Sciences and Peking Union Medical College  Shenzhen China"},{"name":"State Key Laboratory of Molecular Oncology, Department of Pathology, National Cancer Centre\/National Clinical Research Centre for Cancer\/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feiyan","family":"Deng","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, National Cancer Center\/National Clinical Research Centre for Cancer\/Cancer Hospital &amp; 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Shenzhen Hospital Chinese Academy of Medical Sciences and Peking Union Medical College  Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lingling","family":"Feng","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, National Cancer Center\/National Clinical Research Centre for Cancer\/Cancer Hospital &amp; Shenzhen Hospital Chinese Academy of Medical Sciences and Peking Union Medical College  Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yexiong","family":"Li","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Molecular Oncology, Department of Radiation Oncology, National Cancer Center\/National Clinical Research Centre for Cancer\/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yinggang","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Colorectal Surgery, National Cancer Centre\/National Clinical Research Centre for Cancer\/Cancer Hospital &amp; 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