{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T17:56:07Z","timestamp":1782496567197,"version":"3.54.5"},"reference-count":17,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2026,2,23]],"date-time":"2026-02-23T00:00:00Z","timestamp":1771804800000},"content-version":"unspecified","delay-in-days":22,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"the \u201cBottleneck\" Technical Breakthrough Talent Support Special Project of Jiangsu Province\u2019s \"333 High-Level Talents\u201d"},{"name":"the Jiangsu Province Hospital (the First Affiliated Hospital with Nanjing Medical University) Clinical Capacity Enhancement Project","award":["JSPH-MB-2023-9"],"award-info":[{"award-number":["JSPH-MB-2023-9"]}]},{"name":"the Beijing Chen Jumei Foundation","award":["Z2025090021"],"award-info":[{"award-number":["Z2025090021"]}]},{"name":"Primary Health Care Foundation of China\u2014\u2014JINGRUI Liver Cancer Young Investigators Research and innovation capacity Building Public Welfare Project"},{"name":"International Scientific Exchange Foundation of China","award":["SWYY2025003061"],"award-info":[{"award-number":["SWYY2025003061"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,12,22]]},"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Intrahepatic cholangiocarcinoma (ICC) has a high recurrence rate after curative surgery, with no standard neoadjuvant therapy. Hepatic arterial infusion chemotherapy (HAIC) has shown efficacy in locally advanced ICC, while immune checkpoint inhibitors and anti-angiogenic agents have demonstrated promising response rates. The NEO-ERA-01 study evaluates the feasibility of neoadjuvant HAIC-GEMOX plus lenvatinib and Adebrelimab in high-risk resectable ICC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>NEO-ERA-01 is a prospective, multicentre, phase II trial using Simon\u2019s two-stage design. Thirty patients with histologically confirmed resectable ICC and high-risk recurrence factors will be enrolled in China. Neoadjuvant therapy consists of HAIC-GEMOX (gemcitabine 800\u2009mg\/m\u00b2, oxaliplatin 85\u2009mg\/m\u00b2 every 3 weeks), lenvatinib (8\u2009mg\/day from Day 5) and Adebrelimab (1200\u2009mg on Day 3, every 3 weeks) for 2\u20134 cycles. Surgery eligibility will be assessed post-treatment. Resected patients will receive adjuvant capecitabine (1250\u2009mg\/m\u00b2 two times per day on Days 1\u201314, every 3 weeks) and Adebrelimab (1200\u2009mg on Day 1, every 3 weeks) for 6 months.<\/jats:p>\n                    <jats:p>The primary endpoint is the completion rate of study treatment. Secondary endpoints include safety, R0 resection rate, response rate, event-free survival, disease-free survival and overall survival. Exploratory endpoints include immune microenvironment and biomarker analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study is approved by the ethics committee of all sites and follows the Declaration of Helsinki and good clinical practice guidelines. Results will be disseminated via peer-reviewed publications and conferences.<\/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=\"NCT06208462\">NCT06208462<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-101101","type":"journal-article","created":{"date-parts":[[2026,2,23]],"date-time":"2026-02-23T13:35:25Z","timestamp":1771853725000},"page":"e101101","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Neoadjuvant hepatic arterial infusion chemotherapy (HAIC) with GEMOX and lenvatinib in combination with adebrelimab for resectable high-risk recurrent intrahepatic cholangiocarcinoma (ICC): study protocol of the NEO-ERA-01 feasibility trial"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct06208462","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06208462","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06208462","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-0378-6221","authenticated-orcid":false,"given":"Yuan","family":"Cheng","sequence":"first","affiliation":[{"name":"Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jinguo","family":"Xia","sequence":"additional","affiliation":[{"name":"Hepatobiliary Centre, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongquan","family":"Chi","sequence":"additional","affiliation":[{"name":"Nanjing Medical University, Nanjing, Jiangsu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianhua","family":"Rao","sequence":"additional","affiliation":[{"name":"Hepatobiliary Centre, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feng","family":"Cheng","sequence":"additional","affiliation":[{"name":"Hepatobiliary Centre, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,2,23]]},"reference":[{"key":"2026062610415026000_16.2.e101101.1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21763"},{"key":"2026062610415026000_16.2.e101101.2","doi-asserted-by":"crossref","DOI":"10.1186\/s12885-022-10286-z","article-title":"Epidemiologic patterns of biliary tract cancer in the United States: 2001-2015","volume":"22","author":"Koshiol","year":"2022","journal-title":"BMC Cancer"},{"key":"2026062610415026000_16.2.e101101.3","doi-asserted-by":"crossref","first-page":"740","DOI":"10.1016\/j.ejso.2020.01.028","article-title":"Intrahepatic cholangiocarcinoma: Limitations for resectability, current surgical concepts and future perspectives","volume":"46","author":"Machairas","year":"2020","journal-title":"Eur J Surg Oncol"},{"key":"2026062610415026000_16.2.e101101.4","unstructured":"Oncology GWCoCSoC: Guideline of Chinese Society of Clinical Oncology (CSCO) Biliary Tract Cancer 2023. 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