{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T09:18:20Z","timestamp":1783588700466,"version":"3.55.0"},"reference-count":19,"publisher":"BMJ","issue":"4","license":[{"start":{"date-parts":[[2026,4,16]],"date-time":"2026-04-16T00:00:00Z","timestamp":1776297600000},"content-version":"unspecified","delay-in-days":15,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Minhang District Science and Technology Commission of Shanghai","award":["2024MHZ056"],"award-info":[{"award-number":["2024MHZ056"]}]},{"name":"the Minhang District Health System Outstanding Young Medical Technical and Pharmacy Talent Training Program, Shanghai Municipality","award":["2025YJYX11"],"award-info":[{"award-number":["2025YJYX11"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,3,31]]},"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Mucosal melanoma (MM) carries a high risk of postoperative relapse and poorer survival than cutaneous disease. Prospective data from China support adjuvant temozolomide\u2013cisplatin (TMZ\/DDP) in resected MM, while radiotherapy (RT) may augment antitumour immunity and synergise with programmed death 1 (PD-1) inhibitor. We therefore designed an adjuvant regimen combining short-course RT (SCRT) with chemotherapy and PD-1 inhibitor after curative-intent resection.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This investigator-initiated, single-arm, prospective, phase II study at Fudan University Shanghai Cancer Centre enrols adults (\u226518 years) with histologically confirmed MM after R0\/R1 resection, Eastern Cooperative Oncology Group (ECOG) performance status 0\u20131 and M0 disease. Patients receive six 3-week cycles of systemic therapy: pucotenlimab 200\u2009mg IV on day 1; TMZ 200\u2009mg\/m\u00b2 orally on days 1\u20135 and DDP 25\u2009mg\/m\u00b2 IV on days 1\u20133. (SCRT; 25\u2009Gy in five fractions) is delivered after the first two cycles of systemic therapy, followed by four additional cycles of systemic therapy without RT. The primary endpoint is 1-year recurrence-free survival (RFS). Secondary endpoints include locoregional RFS, distant metastasis-free survival, overall survival and safety (CTCAE V.5.0). The planned sample size is 47 (44 evaluable), providing 80% power (one-sided \u03b1 of 0.10) to detect an improvement in 1-year RFS from 55% to 70%. Time-to-event endpoints will be estimated using Kaplan\u2013Meier methods with 95% CIs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The protocol was approved by the Ethics Committee of Fudan University Shanghai Cancer Centre (approval number: 2407300-5), and all participants will provide written informed consent. Findings will be disseminated in peer-reviewed journals and at scientific conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ChiCTR2400093001.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-114414","type":"journal-article","created":{"date-parts":[[2026,4,16]],"date-time":"2026-04-16T16:15:53Z","timestamp":1776356153000},"page":"e114414","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Adjuvant short-course radiotherapy combined with chemotherapy and a PD-1 inhibitor for resected mucosal melanoma: study protocol for a single-arm, prospective, phase II trial"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct04462965","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06455124","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04318717","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06455124","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-3480-6301","authenticated-orcid":false,"given":"Jiaojie","family":"Lv","sequence":"first","affiliation":[{"name":"Department of Pathology, Fudan University Shanghai Cancer Centre, Shanghai, China"},{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lijun","family":"Shen","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"},{"name":"Department of Radiation Oncology, Fudan University Shanghai Cancer Centre, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xuebing","family":"Jiang","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"},{"name":"Department of Pathology, Fudan University Minhang Hospital, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruiyan","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"},{"name":"Department of Radiation Oncology, Fudan University Shanghai Cancer Centre, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shujuan","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"},{"name":"Department of Radiation Oncology, Fudan University Shanghai Cancer Centre, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhiyuan","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"},{"name":"Department of Radiation Oncology, Fudan University Shanghai Cancer Centre, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5361-1663","authenticated-orcid":false,"given":"Juefeng","family":"Wan","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"},{"name":"Department of Radiation Oncology, Fudan University Shanghai Cancer Centre, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lingfang","family":"Xia","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"},{"name":"Department of Gynaecological Oncology, Fudan University Shanghai Cancer Centre, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fangqi","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"},{"name":"Department of Colorectal Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xin","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"},{"name":"Department of Medical Oncology, Fudan University Shanghai Cancer Centre, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7188-4566","authenticated-orcid":false,"given":"Yong","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"},{"name":"Department of Musculoskeletal Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8750-9341","authenticated-orcid":false,"given":"Yan","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"},{"name":"Department of Radiation Oncology, Fudan University Shanghai Cancer Centre, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhen","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"},{"name":"Department of Radiation Oncology, Fudan University Shanghai Cancer Centre, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,4,16]]},"reference":[{"key":"2026070902003630000_16.4.e114414.1","doi-asserted-by":"crossref","DOI":"10.1155\/2021\/9989824","article-title":"Temporal Trends in the Incidence and Mortality of Skin Malignant Melanoma in China from 1990 to 2019","volume":"2021","author":"Bai","year":"2021","journal-title":"J Oncol"},{"key":"2026070902003630000_16.4.e114414.2","doi-asserted-by":"crossref","DOI":"10.1186\/1471-2407-11-85","article-title":"Clinical presentation, histology, and prognoses of malignant melanoma in ethnic Chinese: a study of 522 consecutive cases","volume":"11","author":"Chi","year":"2011","journal-title":"BMC Cancer"},{"key":"2026070902003630000_16.4.e114414.3","doi-asserted-by":"publisher","DOI":"10.1245\/s10434-018-6503-9"},{"key":"2026070902003630000_16.4.e114414.4","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-13-0739"},{"key":"2026070902003630000_16.4.e114414.5","doi-asserted-by":"crossref","DOI":"10.21037\/atm-21-5738","article-title":"Combination of pembrolizumab plus temozolomide therapy in unresectable and advanced melanoma: a multicenter retrospective analysis in China","volume":"9","author":"Hu","year":"2021","journal-title":"Ann Transl Med"},{"key":"2026070902003630000_16.4.e114414.6","doi-asserted-by":"crossref","DOI":"10.1038\/s41392-020-0150-x","article-title":"DNA damage response signaling pathways and targets for radiotherapy sensitization in cancer","volume":"5","author":"Huang","year":"2020","journal-title":"Signal Transduct Target Ther"},{"key":"2026070902003630000_16.4.e114414.7","doi-asserted-by":"publisher","DOI":"10.1038\/nrc3380"},{"key":"2026070902003630000_16.4.e114414.8","doi-asserted-by":"publisher","DOI":"10.1158\/0008-5472.CAN-15-3142"},{"key":"2026070902003630000_16.4.e114414.9","doi-asserted-by":"publisher","DOI":"10.1126\/science.1244040"},{"key":"2026070902003630000_16.4.e114414.10","doi-asserted-by":"crossref","first-page":"528","DOI":"10.1016\/j.ijrobp.2024.03.021","article-title":"Efficacy and Safety of Postoperative Adjuvant Radiation Therapy in Resected Nasal Cavity and Paranasal Sinus Mucosal Melanoma: A Combined Analysis","volume":"120","author":"Lian","year":"2024","journal-title":"Int J Radiat Oncol Biol Phys"},{"key":"2026070902003630000_16.4.e114414.11","doi-asserted-by":"crossref","first-page":"584","DOI":"10.1002\/lary.29807","article-title":"Adjuvant Therapy and Prognosticators of Survival in Head and Neck Mucosal Melanoma","volume":"132","author":"Abiri","year":"2022","journal-title":"Laryngoscope"},{"key":"2026070902003630000_16.4.e114414.12","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijrobp.2003.11.013"},{"key":"2026070902003630000_16.4.e114414.13","doi-asserted-by":"crossref","first-page":"1145","DOI":"10.1158\/1078-0432.CCR-25-2733","article-title":"Differential Immunologic Effects of Short-Course and Long-Course Radiotherapy in Locally Advanced Rectal Cancer","volume":"32","author":"Hillson","year":"2026","journal-title":"Clin Cancer Res"},{"key":"2026070902003630000_16.4.e114414.14","doi-asserted-by":"crossref","first-page":"74","DOI":"10.1016\/j.ijrobp.2018.01.071","article-title":"Targeting Myeloid-derived Suppressor Cells and Programmed Death Ligand 1 Confers Therapeutic Advantage of Ablative Hypofractionated Radiation Therapy Compared With Conventional Fractionated Radiation Therapy","volume":"101","author":"Lan","year":"2018","journal-title":"Int J Radiat Oncol Biol Phys"},{"key":"2026070902003630000_16.4.e114414.15","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-09-0265"},{"key":"2026070902003630000_16.4.e114414.16","doi-asserted-by":"crossref","DOI":"10.1186\/s12885-022-09348-z","article-title":"Short-course radiotherapy combined with CAPOX and Toripalimab for the total neoadjuvant therapy of locally advanced rectal cancer: a randomized, prospective, multicentre, double-arm, phase II trial (TORCH)","volume":"22","author":"Wang","year":"2022","journal-title":"BMC Cancer"},{"key":"2026070902003630000_16.4.e114414.17","doi-asserted-by":"crossref","first-page":"882","DOI":"10.1016\/j.annonc.2024.06.015","article-title":"Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy in locally advanced rectal cancer (UNION): early outcomes of a multicenter randomized phase III trial","volume":"35","author":"Lin","year":"2024","journal-title":"Ann Oncol"},{"key":"2026070902003630000_16.4.e114414.18","unstructured":"ClinicalTrials.gov . Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE), 2024. Available: https:\/\/clinicaltrials.gov\/study\/NCT06455124 [Accessed 17 Mar 2026]."},{"key":"2026070902003630000_16.4.e114414.19","doi-asserted-by":"crossref","DOI":"10.1200\/JCO.2022.40.16_suppl.9578","article-title":"Adjuvant temozolomide plus cisplatin versus high-dose interferon alpha-2b in resected mucosal melanoma: A randomized, multicenter, controlled, phase III trial","volume":"40","author":"Lian","year":"2022","journal-title":"JCO"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2025-114414","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T09:01:21Z","timestamp":1783587681000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2025-114414"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4]]},"references-count":19,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2026,4,16]]},"published-print":{"date-parts":[[2026,4]]}},"alternative-id":["10.1136\/bmjopen-2025-114414"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2025-114414","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4]]}}}