[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619184":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":29,"interventions":23,"overallOfficials":36,"centralContacts":45,"locations":55,"responsibleParty":123,"collaborators":125,"id":134,"slug":135,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":136,"sex":142,"minAge":23,"maxAge":23,"enrollmentInfo":143,"targetDuration":23,"studyType":146,"phases":23,"briefSummary":147,"conditions":148,"keywords":152,"overallStatus":57,"whyStopped":23,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Medical University of Graz","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Best overall response","according to mRECIST criteria","up to 4 years",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Overall survival","death yes\u002Fno",{"measure":18,"description":19,"timeFrame":12},"Progression free survival","Progression according to RECIST yes\u002Fno",{"measure":21,"description":22,"timeFrame":12},"Time to progression","Time until progression occurs according to RECIST",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"CASE_CONTROL","RETROSPECTIVE","Immune checkpoint inhibitors (ICIs) have become a cornerstone of systemic therapy for advanced hepatocellular carcinoma (HCC). Their efficacy, however, varies substantially between patients, and factors that modulate immunotherapy response remain incompletely understood .\n\nRecent mechanistic and clinical data have raised the hypothesis that SARS-CoV-2 mRNA vaccines might augment responsiveness to ICIs. A landmark study by Grippin et al. demonstrated that mRNA vaccines induce a systemic surge of type-I interferons, activate antigen-presenting cells, increase PD-L1 expression on tumor cells, and ultimately sensitize tumors to ICIs across various malignancies including NSCLC (non-small cell lung cancer) and melanoma. In their retrospective cohorts, receiving a COVID-19 mRNA vaccine within 100 days before starting ICI was associated with significantly improved overall survival and progression-free survival While these findings suggest that COVID-19 mRNA vaccines may act as potent immune modulators in the context of immunotherapy, no data exist for HCC, a tumor entity that is characterized by an immunosuppressive, 'immune-cold' microenvironment that limits effective anti-tumor immune responses.\n\nGiven the widespread implementation of COVID-19 vaccination programs in Austria since 2021, and the large number of HCC patients receiving ICI-based therapies at tertiary centers, a rigorous retrospective analysis is now feasible.","The study will include all eligible patients with HCC treated within the past 5 years (January 2021 - December 2025, depending on center availability) with one of the specified checkpoint inhibitors",[30,33],{"label":31,"type":23,"description":32,"interventionNames":23},"Vaccinated","Patients with hepatocellular carcinoma, undergoing checkpoint inhibitor therapy, vaccinated with mRNA vaccine within last 100 days",{"label":34,"type":23,"description":35,"interventionNames":23},"not vaccinated","Patients with hepatocellular carcinoma, undergoing checkpoint inhibitor therapy, not vaccinated with mRNA vaccine within last 100 days",[37,41,43],{"name":38,"affiliation":39,"role":40},"Florian Rainer, MD","Medizinische Universität Graz","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":39,"role":40},"Vanessa Stadlbauer, Univ Prof",{"name":44,"affiliation":39,"role":40},"Walter Spindelböck, MD",[46,51],{"name":38,"role":47,"phone":48,"phoneExt":49,"email":50},"CONTACT","+43 316 385","30164","florian.rainer@medunigraz.at",{"name":52,"role":47,"phone":48,"phoneExt":53,"email":54},"Vanessa Stadlbauer, Univ. Prof. MD","82282","vanessa.stadlbauer@medunigraz.at",[56,70,84,97,110],{"facility":5,"status":57,"city":58,"state":23,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","Graz","8010","Austria","AT",{"type":63,"coordinates":64},"Point",[65,66],15.44197,47.06733,{"lat":66,"lon":65},[69],{"name":38,"role":47,"phone":48,"phoneExt":23,"email":50},{"facility":71,"status":72,"city":73,"state":23,"zip":23,"country":60,"countryCode":61,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Ordensklinikum Linz","NOT_YET_RECRUITING","Linz",{"type":63,"coordinates":75},[76,77],14.28611,48.30639,{"lat":77,"lon":76},[80],{"name":81,"role":47,"phone":82,"phoneExt":23,"email":83},"Stephanie Hametner-Schreil","+43 732 7677","Stephanie.Hametner-Schreil@ordensklinikum.at",{"facility":85,"status":72,"city":86,"state":23,"zip":23,"country":60,"countryCode":61,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"University Hospital St. Pölten","Sankt Pölten",{"type":63,"coordinates":88},[89,90],15.63725,48.20762,{"lat":90,"lon":89},[93],{"name":94,"role":47,"phone":95,"phoneExt":23,"email":96},"Anderas Maieron, MD","+43 27429004","andreas.maieron@stpoelten.lknoe.at",{"facility":98,"status":57,"city":99,"state":23,"zip":23,"country":60,"countryCode":61,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Krankenhaus der Barmherzigen Brüder St Veit an der Glan","Sankt Veit an der Glan",{"type":63,"coordinates":101},[102,103],14.36028,46.76806,{"lat":103,"lon":102},[106],{"name":107,"role":47,"phone":108,"phoneExt":23,"email":109},"Ute Enökl-Tomantschger, MD","+43 4212 499","Ute.Enoekl-Tomantschger@bbstveit.at",{"facility":111,"status":72,"city":112,"state":23,"zip":23,"country":60,"countryCode":61,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Klinikum Wels-Grieskirchen","Wels",{"type":63,"coordinates":114},[115,116],14.03333,48.16667,{"lat":116,"lon":115},[119],{"name":120,"role":47,"phone":121,"phoneExt":23,"email":122},"Harald Hofer, MD","+43 7242 415 - 2181","harald.hofer@klinikum-wegr.at",{"type":124,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[126,127,129,132],{"name":111,"class":6},{"name":128,"class":6},"University Hospital St. Polten",{"name":130,"class":131},"Ordensklinikum Linz GmbH Krankenhaus Barmherzige Schwestern","UNKNOWN",{"name":133,"class":131},"Krankenhaus der Barmherzigen Brüder St. Veit\u002FGlan","100619184","sars-cov-2-mrna-vaccination-in-patients-with-hepatocellular-carcinoma-treated-with-immune-checkpoint-inhibitors-100619184",false,"NCT07341321","SARS-CoV-2 mRNA Vaccination in Patients With Hepatocellular Carcinoma Treated With Immune Checkpoint Inhibitors","SARS-CoV-2 mRNA Vaccination in Patients With Hepatocellular Carcinoma Treated With Immune Checkpoint Inhibitors (CoVaCheck) A Multicenter Retrospective Cohort Analysis in Austria","CoVaCheck","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Radiologically or histologically confirmed hepatocellular carcinoma\n* Treatment with immune checkpoint inhibitor-based therapy (mono- or combination therapy; e.g., atezolizumab\u002Fbevacizumab, durvalumab\u002Ftremelimumab, nivolumab, pembrolizumab)\n* Complete electronic medical records available\n* At least one imaging-based response assessment using mRECIST\n\nExclusion Criteria:\n\n* Missing key clinical data required for main analyses (e.g. survival status, date of progression, Child-Pugh class, BCLC stage)","ALL",{"count":144,"type":145},200,"ESTIMATED","OBSERVATIONAL","A multicenter retrospective cohort analysis in Austria\n\nPrimary Objective:\n\nTo assess whether receiving an mRNA COVID-19 vaccine within 3 months before starting ICI (Immune checkpoint inhibitors) therapy improves best overall response (mRECIST) in HCC (hepatocellular carcinoma).\n\nSecondary Objectives:\n\nEvaluate whether vaccination within 1 or 3 months affects OS (overall survival) , PFS (Progression free survival)), or TTP (Time to progression); compare outcomes by vaccination status, vaccine type, and prior infection; explore modification by cirrhosis severity and tumor characteristics; and assess safety (irAEs, steroid use, toxicity-related discontinuation).",[149,150,151],"mRNA Vaccination","Hepatocellular Carcinoma","Checkpoint Inhibitor",[153,154,155,156],"hepatocellular carcinoma","mRNA vaccination","response","immune checkpoint inhibitor","2026-10-07",{"date":159,"type":160},"2026-10-08","ACTUAL",{"date":162,"type":160},"2026-01-01",{"date":164,"type":145},"2027-12",{"name":5,"class":6},5]