protocolSection identificationModule nctId: NCT06313203, orgStudyIdInfo id: 'TOMCAT' SMR-4066, briefTitle: HAI-Floxuridine, or SIRT, Combined With Gemox For Patients With Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT), acronym: TOMCAT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2031-01, completionDateStruct date: 2034-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Oslo University Hospital, class: OTHER, descriptionModule briefSummary: Patients with intrahepatic cholangiocarcinoma (IHC) have relatively aggressive tumors, and the prognosis for most of these patients is dismal. Surgery is the only option that can offer potential cure, but only an estimated 20-25 % are amenable to resection. Down-staging conventional chemotherapy has a relatively low response rate (\< 50 %). Patients will be included into the respective treatment arms based on their tumour characteristics and disease stage, but also based on their ability/preferences, as HAI-FUDR/DEX requires going to Oslo every fortnight for the duration of the treatment and SIRT has some limitations regarding tumour distribution.Data from the MSKCC has suggested a clinically relevant benefit from adding intrahepatic chemotherapy to systemic therapy. HAI-FUDR/DEX is not approved in Norway and can only be evaluated in a protocolized trial. Given the risk of distant disease progression with IHC, the addition of conventional systemic chemotherapy makes good clinical sense, and data from MSKCC supports this approach. SIRT is another modality also applied trans-arterially and directly into the tumour. This treatment is approved in Norway and available in Bergen and in Oslo. It is far less cumbersome to deliver and maintain than HAI-FUDR/DEX. The efficacy and safety of the two treatment groups, HAI-FUDR/DEX and SIRT, will be compared in a parallel cohort (non-randomized) design, conditionsModule conditions: Intrahepatic Cholangiocarcinoma, conditions: Chemotherapy Effect, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: Floxuridine, interventions name: Selective Internal Radiation Therapy (SIRT), outcomesModule primaryOutcomes measure: Overall Survival (OS) at 3 years, secondaryOutcomes measure: Tumor response, secondaryOutcomes measure: Quality of Life by using EORTC QLQ-C30, secondaryOutcomes measure: Quality of Life by using EQ-5D-5L, secondaryOutcomes measure: Assess the resection rate following downstaging, secondaryOutcomes measure: Assess complications, toxicity and side effects in treatment groups, secondaryOutcomes measure: Assess circulating cell-free (ctDNA) before and after treatment and correlate with treatment outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oslo University Hospital, status: RECRUITING, city: Oslo, zip: 0424, country: Norway, contacts name: Anne H Longva, MD, role: CONTACT, phone: 90797458, phoneExt: +47, email: anlong@ous-hf.no, contacts name: Kristoffer Lassen, MD PhD, role: CONTACT, phone: 47616906, phoneExt: +47, email: krlass@ous-hf.no, geoPoint lat: 59.91273, lon: 10.74609, hasResults: False