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Pre-enrollment biopsy excluded FGFR2-altered cases, and 23 eligible patients were treated until progression or intolerable adverse events. Partial responses were observed in 12 patients, yielding an objective response rate of 52.2%. Median PFS was 11.3 months and median OS 20.3 months, with 18 patients experiencing AEs including one grade 3 event. Exploratory analyses linked higher tumor PD-L1 expression with improved response.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/locoregional-gemcitabine-plus-surufatinib-and-camrelizumab-in-fgfr2-non-altered-intrahepatic-cholangiocarcinoma-clinical-efficacy-and-manageable-safety-in-a-phase-2-trial/433888/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/locoregional-gemcitabine-plus-surufatinib-and-camrelizumab-in-fgfr2-non-altered-intrahepatic-cholangiocarcinoma-clinical-efficacy-and-manageable-safety-in-a-phase-2-trial/433888.png","ImageObject",300,407,{"name":92,"@type":93},"Asher","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-30","2026-09-29",true,{"@type":102,"interactionType":103,"userInteractionCount":44},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What patient population was studied in this phase 2 trial?","Question",{"text":112,"@type":113},"Patients with advanced intrahepatic cholangiocarcinoma were screened by pre-enrollment biopsy, and those with FGFR2 alterations were excluded. The study enrolled 23 eligible FGFR2-non-altered patients.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How was the treatment administered in the locoregional combination regimen?",{"text":117,"@type":113},"Eligible patients received locoregional gemcitabine combined with camrelizumab and surufatinib, continued until disease progression or intolerable adverse events.",{"name":119,"@type":110,"acceptedAnswer":120},"What were the efficacy and survival outcomes reported?",{"text":121,"@type":113},"The objective response rate was 52.2%. Median progression-free survival was 11.3 months and median overall survival was 20.3 months.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},433888,1790763467,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":44,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145,"preview_page_count":4},687197207639,"https://ap-avatar.wpscdn.com/davatar_a8503ba1806abce46bf441b54a3ca4cd","Article  \nLocoregional gemcitabine plus surufatinib and camrelizumab in FGFR2-non-altered intrahepatic cholangiocarcinoma  \nGraphical abstract  \n\n| Screening Process\u003Cbr>|  |\n| --- | --- |\n| Treatment Strategy\u003Cbr>Synergistic Antitumor Activity\u003Cbr> Gemcitabine\u003Cbr> DEB-TACE or HAIC\u003Cbr> Every 4-8 weeks  Camrelizumab\u003Cbr> Intravenous infusion\u003Cbr> 200 mg (every 3 weeks)  Surufatinib\u003Cbr> Oral administration\u003Cbr> 250 mg (every day)\u003Cbr>|  |\n| Efficacy and safety\u003Cbr>100%\u003Cbr>75% \u003Cbr>50% \u003Cbr>\u003Cbr>\u003Cbr>25% \u003Cbr>0% \u003Cbr>Median PFS 11.3 months\u003Cbr>0 6 12 18 24 30\u003Cbr>100%\u003Cbr>\u003Cbr>\u003Cbr>+ + +\u003Cbr>\u003Cbr>75% \u003Cbr>\u003Cbr>\u003Cbr>50%\u003Cbr>25%\u003Cbr>0%\u003Cbr>0 6 12 18 24 30\u003Cbr> Objective response rate: 52.2%  Grade 1-2 AE: 17/23, 73.9%; Grade 3 AE: 1/23, 4.3% |  |\n\nHighlights  \nAuthors  \nBin Guo, Yunhui Fan, Danfeng Li, ...,  \nShuai Xiang, Enyu Liu, Wanguang Zhang  \nCorrespondence  \n[xiangshuai_hust@163.com](xiangshuai_hust@163.com) (S.X.),  \n[liuenyu@163.com](liuenyu@163.com) (E.L.),  \n[wgzhang@tjh.tjmu.edu.cn](wgzhang@tjh.tjmu.edu.cn) (W.Z.)  \nIn brief  \nIn a phase 2 trial, [Guo et al. report](Guo et al. report) that combining locoregional gemcitabine with camrelizumab and surufatinib demonstrates promising efficacy and manageable safety in intrahepatic cholangiocarcinoma patients without FGFR2 alterations, offering a potential treatment for this population.  \n• The combination therapy is clinically feasible for advanced FGFR2-non-altered ICC  \n• The ORR is 52.2%, and the median OS is 20.3 months  \n• The safety profile is manageable, with only one grade 3 AE observed  \n• Higher tumor PD-L1 expression is associated with improved treatment response  \nGuo et al., 2025, Cell Reports Medicine 6, 102482  \nDecember 16, 2025 © 2025 The Authors. Published by Elsevier Inc.  \n[https://doi.org/10.1016/j.xcrm.2025.102482](https://doi.org/10.1016/j.xcrm.2025.102482)  \nll  \nll  \nOPEN ACCESS  \nArticle  \nLocoregional gemcitabine plus surufatiniband camrelizumab in FGFR2-non-altered intrahepatic cholangiocarcinoma  \nBin Guo,1,6 Yunhui Fan,1,6 Danfeng Li,1,6 Feng Xia,1,6 Chu Luo,1 Jinghan Zhu,1 Yang Wu,1 Zhiwen Zhu,1 Shuai Xiang,1,* Enyu Liu,2,3,* and Wanguang Zhang1,4,5,7,*  \n1Division of Hepato-Pancreato-Biliary Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430000, China  \n2Organ Transplant Department, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, 250012, China  \n3Department of General Surgery, Qilu Hospital of Shandong University Dezhou hospital, De zhou, 253000, China  \n4Hubei key Laboratory of Hepao-Pancreato-Biliary Disease, Wuhan, Hubei, China  \n5Key Laboratory of Organ Transplantation, Ministry of Education, NHC Key Laboratory of Organ Transplantation, Chinese Academy of Medical Sciences, Wuhan, Hubei, China  \n6These authors contributed equally  \n7Lead contact  \n*[Correspondence:](Correspondence: xiangshuai_hust@163.com)[ xiangshuai_hust@163.com](Correspondence: xiangshuai_hust@163.com) (S.X.), [liuenyu@163.com](liuenyu@163.com) (E. L.), [wgzhang@tjh.tjmu.edu.cn](wgzhang@tjh.tjmu.edu.cn) (W.Z.) [https://doi.org/10.1016/j.xcrm.2025.102482](https://doi.org/10.1016/j.xcrm.2025.102482)  \nSUMMARY  \nAlterations in fibroblast growth factor receptor 2 (FGFR2) represent potential therapeutic targets in intrahepatic cholangiocarcinoma (ICC), yet they occur in only about 10% of patients. In this study, patients with advanced ICC are tested for FGFR2 alterations via pre-enrollment biopsy; those with alterations are excluded. Eligible patients receive locoregional gemcitabine combined with camrelizumab and surufatinib until disease progression or intolerable adverse events (AEs) . Between July 2022 and June 2024, 23 eligible patients are enrolled. Twelve patients achieve partial response, resulting in an objective response rate of 52.2% . The median progression-free survival is 11.3 months, and the median overall survival is 20.3 months. Eighteen patients experience at least oneAE, including one grade 3 event. Explo","cbCaiv7YWJpcecQG","https://ap.wps.com/l/cbCaiv7YWJpcecQG","pdf",2415953,11,"English","# Summary\n# Highlights\n# Authors and Correspondence\n# In brief\n# Summary (Trial outcomes)\n# Introduction\n## Background of intrahepatic cholangiocarcinoma\n## Current treatments and unmet need\n## Targeted therapy and immunotherapy context","[{\"question\":\"What patient population was studied in this phase 2 trial?\",\"answer\":\"Patients with advanced intrahepatic cholangiocarcinoma were screened by pre-enrollment biopsy, and those with FGFR2 alterations were excluded. The study enrolled 23 eligible FGFR2-non-altered patients.\"},{\"question\":\"How was the treatment administered in the locoregional combination regimen?\",\"answer\":\"Eligible patients received locoregional gemcitabine combined with camrelizumab and surufatinib, continued until disease progression or intolerable adverse events.\"},{\"question\":\"What were the efficacy and survival outcomes reported?\",\"answer\":\"The objective response rate was 52.2%. Median progression-free survival was 11.3 months and median overall survival was 20.3 months.\"}]","Locoregional gemcitabine plus surufatinib and camrelizumab in FGFR2-non-altered intrahepatic cholangiocarcinoma - Clinical efficacy and manageable safety in a phase 2 trial | PDF",1790665877,28]