{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T22:14:08Z","timestamp":1780352048106,"version":"3.54.1"},"reference-count":24,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2024,2,2]],"date-time":"2024-02-02T00:00:00Z","timestamp":1706832000000},"content-version":"unspecified","delay-in-days":1,"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":["82272732"],"award-info":[{"award-number":["82272732"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Guangzhou Shared Future Charitable Foundation","award":["2021-DF-015"],"award-info":[{"award-number":["2021-DF-015"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,1,18]]},"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The preliminary result of the TORCH trial has shown a promising complete response (CR) for managing locally advanced rectal cancer with neoadjuvant short-course radiotherapy (SCRT) combined with chemotherapy and PD-1 inhibitor. For locally advanced colon cancer (LACC) with bulky nodal disease and\/or clinically T4, neoadjuvant chemotherapy followed by colectomy with en bloc removal of regional lymph nodes is the suggested treatment. However, the CR rate is less than 5%. TORCH-C will aim to investigate neoadjuvant SCRT combined with chemotherapy and PD-1 inhibitor in LACC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>TORCH-C is a randomised, prospective, multicentre, double-arm, open, phase II trial of SCRT combined with chemotherapy and immunotherapy in LACC with microsatellite stable (MSS) patients and cT4 or bulky nodes. Eligible patients will be identified by the multidisciplinary team. 120 patients will be randomised 1:1 to the intervention or control arm. The patients in the control arm will receive four cycles of capecitabine plus oxaliplatin (CAPOX). The patients in the intervention arm will receive SCRT, followed by four cycles of CAPOX and PD-1 inhibitor (serplulimab). Both arms will receive curative surgery, followed by four cycles of CAPOX. The primary endpoint is pathological complete regression.<\/jats:p>\n                    <jats:p>TORCH-C (TORCH-colon) trial aims to investigate whether the combination of immunotherapy and chemoradiotherapy improves the treatment effect in LACC with MSS. TORCH-C will establish the TORCH platform, a key part of our long-term strategy to develop neoadjuvant treatment for colorectal cancer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study was approved by the Ethics Committee of Fudan University Shanghai Cancer Center (approval number: 2211265-12).<\/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=\"NCT05732493\">NCT05732493<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-079442","type":"journal-article","created":{"date-parts":[[2024,2,3]],"date-time":"2024-02-03T01:27:21Z","timestamp":1706923641000},"page":"e079442","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["Study protocol of short-course radiotherapy combined with CAPOX and PD-1 inhibitor for locally advanced colon cancer: a randomised, prospective, multicentre, phase II trial (TORCH-C)"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct05732493","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04518280","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05732493","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8803-2696","authenticated-orcid":false,"given":"Hui","family":"Zhang","sequence":"first","affiliation":[{"name":"Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China"},{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaqi","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fan","family":"Xia","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China"},{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yiqun","family":"Sun","sequence":"additional","affiliation":[{"name":"Department of Radiology, Fudan University Shanghai Cancer Center, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lijun","family":"Shen","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China"},{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juefeng","family":"Wan","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China"},{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-9233-2572","authenticated-orcid":false,"given":"Yajie","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China"},{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaqi","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China"},{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Menglong","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China"},{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruiyan","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China"},{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shujuan","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China"},{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China"},{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fangqi","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanjun","family":"Cai","sequence":"additional","affiliation":[{"name":"Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhen","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China"},{"name":"Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,2,2]]},"reference":[{"key":"2025121410163747000_14.2.e079442.1","first-page":"409","article-title":"Cancer treatment and survivorship statistics, 2022","volume":"72","author":"Miller","year":"2022","journal-title":"CA Cancer J Clin"},{"key":"2025121410163747000_14.2.e079442.2","doi-asserted-by":"crossref","first-page":"5","DOI":"10.3109\/0284186X.2014.975839","article-title":"Risk of recurrence in patients with colon cancer stage II and III: a systematic review and meta-analysis of recent literature","volume":"54","author":"B\u00f6ckelman","year":"2015","journal-title":"J Acta Oncol"},{"key":"2025121410163747000_14.2.e079442.3","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2021.0012"},{"key":"2025121410163747000_14.2.e079442.4","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.22.00046"},{"key":"2025121410163747000_14.2.e079442.5","doi-asserted-by":"crossref","first-page":"95","DOI":"10.1186\/s13014-022-02064-9","article-title":"Postoperative locoregional recurrence pattern and treatment management of stage pT4 sigmoid colon cancer: a retrospective cohort study","volume":"17","author":"Lin","year":"2022","journal-title":"J Radiat Oncol"},{"key":"2025121410163747000_14.2.e079442.6","doi-asserted-by":"crossref","first-page":"856","DOI":"10.1245\/s10434-015-4907-3","article-title":"Role of Adjuvant Radiotherapy in Locally Advanced Colonic Carcinoma in the Modern Chemotherapy Era","volume":"23","author":"Ludmir","year":"2016","journal-title":"J Ann Surg Oncol"},{"key":"2025121410163747000_14.2.e079442.7","doi-asserted-by":"crossref","first-page":"825","DOI":"10.1245\/s10434-019-08042-y","article-title":"Utilization of Adjuvant Radiotherapy for Resected Colon Cancer and Its Effect on Outcome","volume":"27","author":"Wegner","year":"2020","journal-title":"J Ann Surg Oncol"},{"key":"2025121410163747000_14.2.e079442.8","doi-asserted-by":"crossref","DOI":"10.1186\/s40880-016-0126-y","article-title":"Outcomes of preoperative chemoradiotherapy followed by surgery in patients with unresectable locally advanced sigmoid colon cancer","volume":"35","author":"Qiu","year":"2016","journal-title":"J Chin J Cancer"},{"key":"2025121410163747000_14.2.e079442.9","doi-asserted-by":"crossref","first-page":"409","DOI":"10.2147\/OTT.S150367","article-title":"Neoadjuvant chemoradiotherapy followed by surgery in patients with unresectable locally advanced colon cancer: a prospective observational study","volume":"11","author":"Chang","year":"2018","journal-title":"J Onco Targets Ther"},{"key":"2025121410163747000_14.2.e079442.10","doi-asserted-by":"crossref","DOI":"10.1186\/s12885-021-07894-6","article-title":"Neoadjuvant chemoradiotherapy for patients with unresectable radically locally advanced colon cancer: a potential improvement to overall survival and decrease to multivisceral resection","volume":"21","author":"Yuan","year":"2021","journal-title":"J BMC Cancer"},{"key":"2025121410163747000_14.2.e079442.11","doi-asserted-by":"crossref","first-page":"659","DOI":"10.1016\/S1470-2045(22)00197-8","article-title":"Pembrolizumab versus chemotherapy for microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer (KEYNOTE-177): final analysis of a randomised, open-label, phase 3 study","volume":"23","author":"Diaz","year":"2022","journal-title":"J Lancet Oncol"},{"key":"2025121410163747000_14.2.e079442.12","doi-asserted-by":"crossref","first-page":"373","DOI":"10.1038\/nature14292","article-title":"Radiation and dual checkpoint blockade activate non-redundant immune mechanisms in cancer","volume":"520","author":"Twyman-Saint Victor","year":"2015","journal-title":"J Nature"},{"key":"2025121410163747000_14.2.e079442.13","doi-asserted-by":"crossref","first-page":"437","DOI":"10.1016\/j.ccell.2015.03.015","article-title":"Radiotherapy complements immune checkpoint blockade","volume":"27","author":"Ngiow","year":"2015","journal-title":"J Cancer Cell"},{"key":"2025121410163747000_14.2.e079442.14","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":"J BMC Cancer"},{"key":"2025121410163747000_14.2.e079442.15","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(12)70348-0"},{"key":"2025121410163747000_14.2.e079442.16","doi-asserted-by":"crossref","first-page":"598","DOI":"10.21147\/j.issn.1000-9604.2016.06.06","article-title":"A pilot phase II study of neoadjuvant triplet chemotherapy regimen in patients with locally advanced resectable colon cancer","volume":"28","author":"Zhou","year":"2016","journal-title":"J Chin J Cancer Res"},{"key":"2025121410163747000_14.2.e079442.17","doi-asserted-by":"crossref","first-page":"1381","DOI":"10.1007\/DCR.0b013e3181ab580b","article-title":"Multivisceral resection for colon carcinoma","volume":"52","author":"Croner","year":"2009","journal-title":"J Dis Colon Rectum"},{"key":"2025121410163747000_14.2.e079442.18","doi-asserted-by":"crossref","first-page":"834","DOI":"10.1080\/21691401.2020.1770270","article-title":"The survival benefit of adjuvant radiotherapy for pathological T4N2M0 colon cancer in the Modern Chemotherapy Era: evidence from the SEER database 2004-2015","volume":"48","author":"Huang","year":"2020","journal-title":"J Artif Cells Nanomed Biotechnol"},{"key":"2025121410163747000_14.2.e079442.19","first-page":"469","article-title":"Neoadjuvant radiation for clinical T4 colon cancer: A potential improvement to overall survival","volume":"165","author":"Hawkins","year":"2019","journal-title":"J Surgery"},{"key":"2025121410163747000_14.2.e079442.20","doi-asserted-by":"crossref","first-page":"677","DOI":"10.1016\/j.ejso.2012.05.001","article-title":"Neoadjuvant chemoradiotherapy and multivisceral resection for primary locally advanced adherent colon cancer: a single institution experience","volume":"38","author":"Cukier","year":"2012","journal-title":"J Eur J Surg Oncol"},{"key":"2025121410163747000_14.2.e079442.21","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2004.01.029"},{"key":"2025121410163747000_14.2.e079442.22","doi-asserted-by":"crossref","first-page":"566","DOI":"10.1038\/s41591-020-0805-8","article-title":"Neoadjuvant immunotherapy leads to pathological responses in MMR-proficient and MMR-deficient early-stage colon cancers","volume":"26","author":"Chalabi","year":"2020","journal-title":"J Nat Med"},{"key":"2025121410163747000_14.2.e079442.23","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1136\/jitc-2021-003554","article-title":"Phase II, single-arm trial of preoperative short-course radiotherapy followed by chemotherapy and camrelizumab in locally advanced rectal cancer","volume":"9","author":"Lin","year":"2021","journal-title":"J Immunother Cancer"},{"key":"2025121410163747000_14.2.e079442.24","doi-asserted-by":"crossref","DOI":"10.1186\/s13014-020-01673-6","article-title":"Efficacy and safety-in analysis of short-course radiation followed by mFOLFOX-6 plus avelumab for locally advanced rectal adenocarcinoma","volume":"15","author":"Shamseddine","year":"2020","journal-title":"J Radiat Oncol"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2023-079442","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T18:16:43Z","timestamp":1765736203000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2023-079442"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2]]},"references-count":24,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2024,2,2]]},"published-print":{"date-parts":[[2024,2]]}},"alternative-id":["10.1136\/bmjopen-2023-079442"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2023-079442","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2]]}}}