{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,14]],"date-time":"2026-04-14T17:05:32Z","timestamp":1776186332188,"version":"3.50.1"},"reference-count":19,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2025,9,11]],"date-time":"2025-09-11T00:00:00Z","timestamp":1757548800000},"content-version":"unspecified","delay-in-days":10,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100018904","name":"Beijing Xisike Clinical Oncology Research Foundation","doi-asserted-by":"publisher","award":["Y-HR2022QN-0488"],"award-info":[{"award-number":["Y-HR2022QN-0488"]}],"id":[{"id":"10.13039\/100018904","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Chinese Society of Clinical Oncology (CSCO) Heathcote-Young Oncology Research Fund Project","award":["Y-Young2022-0325"],"award-info":[{"award-number":["Y-Young2022-0325"]}]},{"name":"Talent Project of Hubei Cancer Hospital","award":["2025HBCHQHRC019"],"award-info":[{"award-number":["2025HBCHQHRC019"]}]},{"name":"Research Projects of Biomedical Center of Hubei Cancer Hospital","award":["2022SWZX22"],"award-info":[{"award-number":["2022SWZX22"]}]},{"name":"Wuhan 2022 Knowledge Innovation Project","award":["2022020801010512"],"award-info":[{"award-number":["2022020801010512"]}]},{"name":"The national key clinical specialty construction discipline of breast cancer center, Hubei cancer hospital","award":["HBCHBCC-D01"],"award-info":[{"award-number":["HBCHBCC-D01"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,8,19]]},"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Immunotherapy combined with chemotherapy has shown potential in improving the pathological complete response (pCR) rate in luminal-type breast cancer. This study explores whether the addition of stereotactic body radiotherapy (SBRT) and the bispecific antibody AK112 (Ivonescimab) further enhances treatment efficacy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>This is a single-centre, prospective, phase II trial using Simon\u2019s two-stage design to evaluate the efficacy and safety of neoadjuvant SBRT combined with Ivonescimab and chemotherapy. A total of 50 patients will be enrolled. The primary endpoint is pCR. Secondary endpoints include objective response rate, disease control rate, Residual Cancer Burden Index, 12-month event-free survival, safety and quality of life. Exploratory endpoints include six-point minimal residual disease (MRD) assessment. Data will be analysed using the Kaplan-Meier method and one-sided exact binomial test (alpha=0.05).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>This study has been approved by the ethics committee of Hubei Cancer Hospital (Approval No.: LCKY2024011). Results will be disseminated through peer-reviewed journals and conference presentations.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06402435\">NCT06402435<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-102952","type":"journal-article","created":{"date-parts":[[2025,9,11]],"date-time":"2025-09-11T06:00:41Z","timestamp":1757570441000},"page":"e102952","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Neoadjuvant stereotactic body radiotherapy combined with chemotherapy and Ivonescimab for Chinese luminal-type breast cancer patients: study protocol for a single-arm, open-label, phase II trial"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06402435","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04900363","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Caixun","family":"Zhang","sequence":"first","affiliation":[{"name":"Department of Radiation Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jianping","family":"Bi","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yujie","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zirui","family":"Ke","sequence":"additional","affiliation":[{"name":"Breast cancer center, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, National key clinical specialty discipline construction program, Hubei Provincial Clinical Research Center for Breast Cancer, Wuhan Clinical Research Center for Breast Cancer, Wuhan, Hubei, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zilong","family":"Yuan","sequence":"additional","affiliation":[{"name":"Department of Radiology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hanguang","family":"Ruan","sequence":"additional","affiliation":[{"name":"Department of Thoracic Radiation Oncology, Jiangxi Cancer Hospital, Nanchang, Jiangxi, 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