FOLFOX-HAIC Combined with Lenvatinib and Tislelizumab in Advanced Hepatocellular Carcinoma with Arteriovenous Fistulae: A Real-World Study

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FOLFOX-HAIC Combined with Lenvatinib and Tislelizumab in Advanced Hepatocellular Carcinoma with Arteriovenous Fistulae: A Real-World Study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article FOLFOX-HAIC Combined with Lenvatinib and Tislelizumab in Advanced Hepatocellular Carcinoma with Arteriovenous Fistulae: A Real-World Study Pengen Li, Shumin Fu, Xiao Wang, Yi Chen, Jianbing Wu, Weimin Jiang, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8238087/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background & Aims:​ Patients with advanced hepatocellular carcinoma (HCC) complicated by arteriovenous fistulae (AVF) face a dismal prognosis and derive limited benefit from conventional transarterial chemoembolization (TACE) due to aberrant hemodynamics. This study aimed to evaluate the efficacy and safety of FOLFOX-based hepatic arterial infusion chemotherapy (HAIC) combined with lenvatinib and tislelizumab in this treatment-refractory population. Methods:​ In this retrospective study, 51 patients with advanced HCC and angiographically confirmed AVF who received the above triple-regimen as first-line therapy were enrolled. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR) per mRECIST, AVF closure rate, and safety. Results:​ The median PFS was 9.67 months, and the median OS was 14.63 months. According to mRECIST criteria, the ORR was 72.55%, and the disease control rate (DCR) was 92.16%. The overall AVF closure rate was 87.2%. Critically, multivariate analysis identified AVF closure as an independent protective factor for improved OS (Hazard Ratio [HR] = 0.32, 95% CI: 0.13-0.78, p=0.012).​ Treatment-related adverse events were manageable, with no treatment-related deaths reported. Conclusion:​ The combination of FOLFOX-HAIC, lenvatinib, and tislelizumab demonstrates compelling efficacy by achieving a high rate of AVF closure—a key predictor of survival—along with significant survival benefits and a favorable safety profile in patients with advanced HCC and AVF, representing a novel and effective first-line therapeutic strategy. ​ Hepatocellular carcinoma Arteriovenous fistula Hepatic arterial infusion chemotherapy Lenvatinib Tislelizumab Full Text Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8238087","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":553704205,"identity":"0f906fa3-f866-42a7-80ee-5a44f3444adb","order_by":0,"name":"Pengen Li","email":"","orcid":"","institution":"The Second Affiliated Hospital of Nanchang University","correspondingAuthor":false,"prefix":"","firstName":"Pengen","middleName":"","lastName":"Li","suffix":""},{"id":553704206,"identity":"32e72907-2078-488e-97bf-e37354228eb4","order_by":1,"name":"Shumin Fu","email":"","orcid":"","institution":"The Second Affiliated Hospital of Nanchang 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Study","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"​ Hepatocellular carcinoma, Arteriovenous fistula, Hepatic arterial infusion chemotherapy, Lenvatinib, Tislelizumab","lastPublishedDoi":"10.21203/rs.3.rs-8238087/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8238087/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBackground \u0026amp; Aims:​ Patients with advanced hepatocellular carcinoma (HCC) complicated by arteriovenous fistulae (AVF) face a dismal prognosis and derive limited benefit from conventional transarterial chemoembolization (TACE) due to aberrant hemodynamics. This study aimed to evaluate the efficacy and safety of FOLFOX-based hepatic arterial infusion chemotherapy (HAIC) combined with lenvatinib and tislelizumab in this treatment-refractory population. Methods:​ In this retrospective study, 51 patients with advanced HCC and angiographically confirmed AVF who received the above triple-regimen as first-line therapy were enrolled. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR) per mRECIST, AVF closure rate, and safety. Results:​ The median PFS was 9.67 months, and the median OS was 14.63 months. According to mRECIST criteria, the ORR was 72.55%, and the disease control rate (DCR) was 92.16%. The overall AVF closure rate was 87.2%. Critically, multivariate analysis identified AVF closure as an independent protective factor for improved OS (Hazard Ratio [HR] = 0.32, 95% CI: 0.13-0.78, p=0.012).​ Treatment-related adverse events were manageable, with no treatment-related deaths reported. Conclusion:​ The combination of FOLFOX-HAIC, lenvatinib, and tislelizumab demonstrates compelling efficacy by achieving a high rate of AVF closure—a key predictor of survival—along with significant survival benefits and a favorable safety profile in patients with advanced HCC and AVF, representing a novel and effective first-line therapeutic strategy.\u003c/p\u003e","manuscriptTitle":"FOLFOX-HAIC Combined with Lenvatinib and Tislelizumab in Advanced Hepatocellular Carcinoma with Arteriovenous Fistulae: A Real-World Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-12-03 08:21:44","doi":"10.21203/rs.3.rs-8238087/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"2037bbe3-7af0-4104-98b1-e18581e1d6ef","owner":[],"postedDate":"December 3rd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-12-04T22:23:16+00:00","versionOfRecord":[],"versionCreatedAt":"2025-12-03 08:21:44","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8238087","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8238087","identity":"rs-8238087","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}

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