{"preliminary_commentary":{"by_channel":{"x_thread":4},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"STUDY00016033","nct_id":"NCT04251715","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=study00016033-nct04251715. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Treatment Period 1 - mFOLFIRINOX for 4 cycles (cycle = 14 days) Cycle 1\n\n* Oxaliplatin 85 mg/m2 intravenously (iv) over 2 hours\n* Folinic acid 400 mg/m2 iv over 2 hours\n* Irinotecan 144 mg/m2 iv over 90 minutes\n* Fluorouracil 2,400 mg/m2 continuous infusion over 46 hours\n\nDosages on Cycle 2, 3, and 4 will be reduced by 25%\n\nTreatment Period 2 - HAI delivery of floxuridine + mFOLFIRI for 2 cycles (cycle = 28 days)\n\n* Floxuridine-DEX (with heparin and saline) - 0.12 mg/kg/day; via HAI pump, adjusted for weight and flow rate\n* mFOLFIRI on Day 15\n* Irinotecan 150 mg/m2 iv over 30 minutes to 1 hour\n* Folinic acid 400mg/m2 iv over 30 minutes to 1 hour\n* 5-FU 1200 mg/m2 continuous infusion over 46 hours","label":"mFOLFIRINOX, Floxuridine-DEX, mFOLFIRI","type":"EXPERIMENTAL"}],"collaborators":["Oregon Health and Science University"],"completion_date":{"date":"2024-03-20","type":"ACTUAL"},"conditions":["Liver and Intrahepatic Bile Duct Carcinoma","Stage III Intrahepatic Cholangiocarcinoma AJCC v8","Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8","Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8","Stage IV Intrahepatic Cholangiocarcinoma AJCC v8","Unresectable Intrahepatic Cholangiocarcinoma"],"enrollment":{"count":5,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Dexamethasone","otherNames":["Aacidexam","Adexone","Aknichthol Dexa","Alba-Dex","Alin","Alin Depot","Alin Oftalmico","Amplidermis","Anemul mono","Auricularum","Auxiloson","Baycadron","Baycuten","Baycuten N","Cortidexason","Cortisumman","Decacort","Decadrol","Decadron","Decadron DP","Decalix","Decameth","Decasone R.p.","Dectancyl","Dekacort","Deltafluorene","Deronil","Desamethasone","Desameton","Dexa-Mamallet","Dexa-Rhinosan","Dexa-Scheroson","Dexa-sine","Dexacortal","Dexacortin","Dexafarma","Dexafluorene","Dexalocal","Dexamecortin","Dexameth","Dexamethasone Intensol","Dexamethasonum","Dexamonozon","Dexapos","Dexinoral","Dexone","Dinormon","Fluorodelta","Fortecortin","Gammacorten","Hexadecadrol","Hexadrol","Lokalison-F","Loverine","Methylfluorprednisolone","Millicorten","Mymethasone","Orgadrone","Spersadex","TaperDex","Visumetazone","ZoDex"],"type":"DRUG"},{"name":"Floxuridine","otherNames":["2''-Deoxy-5-fluorouridine","5-Fluoro-2''-deoxyuridine","5-Fluorodeoxyuridine","5-Fluorouracil deoxyriboside","5-FUdR","FDUR","Floxuridin","Fluorodeoxyuridine","Fluorouridine Deoxyribose","Fluoruridine Deoxyribose","FUdR","WR-138720"],"type":"DRUG"},{"name":"Implanted Medical Device","otherNames":["IMPLANTED"],"type":"DEVICE"},{"name":"Irinotecan","otherNames":[],"type":"DRUG"},{"name":"Leucovorin","otherNames":["Folinic acid"],"type":"DRUG"},{"name":"Oxaliplatin","otherNames":["1-OHP","Ai Heng","Aiheng","Dacotin","Dacplat","Diaminocyclohexane Oxalatoplatinum","Eloxatin","Eloxatine","JM-83","Oxalatoplatin","Oxalatoplatinum","RP 54780","RP-54780","SR-96669"],"type":"DRUG"},{"name":"Quality-of-Life Assessment","otherNames":["Quality of Life Assessment"],"type":"OTHER"}],"last_update":"2026-06-25","lead_sponsor":"OHSU Knight Cancer Institute","official_title":"A Phase II Study of Induction Systemic mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone Given Concurrently With Systemic mFOLFIRI as a First-Line Therapy in Patients With Unresectable Liver-Dominant Intrahepatic Cholangiocarcinoma","overall_status":"TERMINATED","phases":["PHASE2"],"primary_completion_date":{"date":"2024-03-20","type":"ACTUAL"},"primary_outcomes":[{"measure":"Frequency of Abnormal Liver Function","timeFrame":"Up to 6 months after starting HAI with floxuridine"},{"measure":"Disease Control Rate (DCR) - During HAI+SYS","timeFrame":"Up to 6 months after starting HAI with floxuridine"}],"references":[{"citation":"Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.","pmid":"15273542","type":"BACKGROUND"},{"citation":"Blair AB, Alobuia WM, Palta M, Raman SS, Levine MH, Benson AB 3rd, D'Angelica MI, Cloyd JM. Locoregional Treatment Options for Locally Advanced Intrahepatic Cholangiocarcinoma. J Natl Compr Canc Netw. 2025 Aug 14;23(9):e257085. doi: 10.6004/jnccn.2025.7085.","pmid":"40812353","type":"DERIVED"}],"start_date":{"date":"2021-04-28","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma","url":"https://clinicaltrials.gov/study/NCT04251715"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/study00016033-nct04251715"}