{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T22:32:25Z","timestamp":1792103545825,"version":"4.4.0"},"reference-count":25,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2025,9,14]],"date-time":"2025-09-14T00:00:00Z","timestamp":1757808000000},"content-version":"unspecified","delay-in-days":13,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Young Scholars Fostering Fund of the First Affiliated Hospital of Nanjing Medical University","award":["PY2023054"],"award-info":[{"award-number":["PY2023054"]}]},{"name":"Nanjing Medical University College Students Innovation and Entrepreneurship Training Program","award":["202410312047Z"],"award-info":[{"award-number":["202410312047Z"]}]},{"name":"Scientific Research Project Support Program of Jiangsu Province Hospital","award":["DL202409"],"award-info":[{"award-number":["DL202409"]}]}],"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>Despite advances in diagnostics, many patients with gastric cancer (GC) or oesophagogastric junction cancer present with advanced disease, most commonly peritoneal metastasis (PM), which conveys a poor prognosis. Hyperthermic intraperitoneal chemotherapy (HIPEC) and anti-programmed cell death protein-1 (PD-1) therapy have each shown promise in GC. We describe the protocol for a study evaluating the efficacy and safety of combining HIPEC with the anti-PD-1 antibody tislelizumab and SOX (oxaliplatin+S-1) chemotherapy in patients with GC\/oesophagogastric junction cancer and PM.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>This is a multicentre, single-arm, phase II trial conducted at 13 high-volume tertiary referral hospitals across China. We will enrol 50 adults (18\u201375 years) with histologically confirmed GC\/oesophagogastric junction adenocarcinoma and PM diagnosed by laparoscopy. Participants will receive one laparoscopy-guided HIPEC cycle (paclitaxel, total dose: 175 mg\/m<jats:sup>2<\/jats:sup>, 3000 mL of physiological saline at 43\u00b0C for 60 min, inflow rate 1.5 L\/min, 10 min physiological saline preconditioning at 41\u00b0C) followed\u2014after a 3-week interval\u2014by up to three 3-week cycles of tislelizumab 200 mg plus SOX (oxaliplatin 130 mg\/m\u00b2 and S-1 dose-escalated by body surface area). HER2-positive patients will also receive trastuzumab. Primary endpoint: 1-year overall survival. Secondary endpoints: 1-year progression-free survival, completeness of Cytoreduction Score and objective response rate. Follow-up includes imaging and toxicity assessments every 3 months for at least 1 year.<\/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 The First Affiliated Hospital of Nanjing Medical University (ID 2024-SR-198). All participants will provide written informed consent. Results will be disseminated via peer-reviewed publications; de-identified individual participant data will be available from the corresponding author on reasonable request after publication.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>ClinicalTrials.gov, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06427252\">NCT06427252<\/jats:ext-link>\n                  <\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-098326","type":"journal-article","created":{"date-parts":[[2025,9,15]],"date-time":"2025-09-15T05:25:26Z","timestamp":1757913926000},"page":"e098326","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Efficacy and safety of HIPEC combined with PD-1 and SOX chemotherapy for gastric or oesophagogastric junctional cancer with peritoneal metastasis (HISTORIA): protocol for a prospective, multicentre, single-arm, phase II study"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06427252","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06427252","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-7305-6676","authenticated-orcid":false,"given":"Yigang","family":"Zhang","sequence":"first","affiliation":[{"name":"Gastric Cancer Center, The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fengyuan","family":"Li","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongda","family":"Liu","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ping","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Oncology, The First Affiliated Hospital With Nanjing Medical University, Nanjing, Jiangsu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qingya","family":"Li","sequence":"additional","affiliation":[{"name":"Department of General Surgery, The First Affiliated Hospital With Nanjing Medical University, Nanjing, Jiangsu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linjun","family":"Wang","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diancai","family":"Zhang","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hao","family":"Wu","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hao","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of General Surgery, The First Affiliated Hospital With Nanjing Medical University, Nanjing, Jiangsu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li","family":"Yang","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ze-Kuan","family":"Xu","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China"},{"name":"Nanjing Medical University, Nanjing, Jiangsu, 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