{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T13:29:59Z","timestamp":1765891799416,"version":"3.48.0"},"reference-count":31,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2024,1,22]],"date-time":"2024-01-22T00:00:00Z","timestamp":1705881600000},"content-version":"unspecified","delay-in-days":21,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["81802445"],"award-info":[{"award-number":["81802445"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004829","name":"Science & Technology Department of Sichuan Province","doi-asserted-by":"crossref","award":["2022NSFSC1564"],"award-info":[{"award-number":["2022NSFSC1564"]}],"id":[{"id":"10.13039\/501100004829","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,1,9]]},"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Radical cystectomy remains the standard treatment for intravesical Bacille Calmette-Guerin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) because potential bladder-preserving therapies are not well established. Combination of radiotherapy with programmed death-1 (PD-1) antibody may offer an optional bladder preservation treatment for high-risk\/extremely high risk NMIBC. Hence, the current study aims to investigate the safety and efficacy of short-course radiotherapy (5\u00d75\u2009Gy) and toripalimab (PD-1 antibody) as a novel bladder sparing treatment in this population.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>HOPE-04 is an open-label, single-arm, phase II study, designed to evaluate the safety and efficacy of short-course radiotherapy and toripalimab in patients with high-risk\/extremely high risk NMIBC. Fifty-five patients with pathological and imaging diagnosed NMIBC with or without BCG treatment will be recruited. Radiotherapy of 5\u00d75\u2009Gy will be given to the whole bladder followed by a focal tumour bed boost and concomitant administration of toripalimab of 240\u2009mg intravenous infusion every 21 days for 12 cycles (about 1 year). The primary endpoints are disease-free survival and safety. The secondary endpoint is overall survival. Additional indicators include implementation rate of salvage surgery and quality of life.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This trial has been approved by the Ethics Committee of West China Hospital, Sichuan University. Trial findings will be disseminated via 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>Chinese Ethics Committee of Registering Clinical Trials (ChiCTR2200059970).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-076663","type":"journal-article","created":{"date-parts":[[2024,1,23]],"date-time":"2024-01-23T01:50:42Z","timestamp":1705974642000},"page":"e076663","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Bladder sparing by short-course radiotherapy combined with toripalimab in high-risk\/extremely high-risk non-muscle invasive bladder cancer (HOPE-04): study protocol for a single-arm, prospective, phase II trial"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct02625961","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02621151","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03747419","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Feng","family":"Wen","sequence":"first","affiliation":[{"name":"Abdominal Oncology Ward, Division of Radiation Oncology, Cancer Center, West China Hospital Sichuan University, Chengdu, Sichuan, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tianhai","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Urology, Institute of Urology, West China Hospital Sichuan University, Chengdu, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peng","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Urology, Institute of Urology, West China Hospital Sichuan University, Chengdu, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hao","family":"Zeng","sequence":"additional","affiliation":[{"name":"Department of Urology, Institute of Urology, West China Hospital Sichuan University, Chengdu, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3750-3042","authenticated-orcid":false,"given":"Qiang","family":"Wei","sequence":"additional","affiliation":[{"name":"Department of Urology, Institute of Urology, West China Hospital Sichuan University, Chengdu, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6416-9516","authenticated-orcid":false,"given":"Yali","family":"Shen","sequence":"additional","affiliation":[{"name":"Abdominal Oncology Ward, Division of Radiation Oncology, Cancer Center, West China Hospital Sichuan University, Chengdu, Sichuan, China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2024,1,22]]},"reference":[{"key":"2025121605260279000_14.1.e076663.1","doi-asserted-by":"crossref","unstructured":"Siegel RL , Miller KD , Wagle NS . 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