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mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma
NCT04251715 · View on ClinicalTrials.gov ↗
Study Summary
This phase II trial studies the efficacy and safety of systemic induction of mFOLFIRINOX, followed by hepatic arterial infusion (HAI) floxuridine-dexamethasone administered concurrently with systemic mFOLFIRI in treating patients with liver-dominant intrahepatic cholangiocarcinoma (ICC) that cannot be removed by surgery (unresectable). Drugs used in chemotherapy regimens, such as mFOLFIRINOX and mFOLFIRI (Oxaliplatin, Irinotecan, Fluorouracil, Folinic acid, Floxuridine) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Delivering chemotherapy via HAI (hepatic arterial infusion) can allow for liver-directed treatment while limiting toxic side effects typically seen with traditional chemotherapy.
Conditions Studied
Interventions
- DRUG Leucovorin
- DRUG Dexamethasone
- DRUG Irinotecan
- DRUG Floxuridine
- DEVICE Implanted Medical Device
Study Locations (1)
Oregon
- OHSU Knight Cancer Institute — Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-04-28 |
| Est. Completion | 2025-11-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04251715
The ClinicalTrials.gov registry entry for NCT04251715 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OHSU Knight Cancer Institute, which has 242 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Stage III Intrahepatic Cholangiocarcinoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions — of which Leucovorin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04251715 reports 1 study location spanning 1 distinct geographic area — top geographies include Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04251715 about?
NCT04251715 is a clinical study titled "mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma". This phase II trial studies the efficacy and safety of systemic induction of mFOLFIRINOX, followed by hepatic arterial infusion (HAI) floxuridine-dexamethasone administered concurrently with systemic mFOLFIRI in treating patients with liver-dominant intrahepatic cholangiocarcinoma (ICC) that cannot ...
What is the current status of trial NCT04251715?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2021-04-28. Estimated completion is 2025-11-30.
What conditions does trial NCT04251715 study?
This clinical trial studies the following conditions: Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Unresectable Intrahepatic Cholangiocarcinoma, Liver and Intrahepatic Bile Duct Carcinoma, Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04251715?
The interventions under investigation include: Leucovorin (DRUG), Dexamethasone (DRUG), Irinotecan (DRUG), Floxuridine (DRUG), Implanted Medical Device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04251715?
This trial is sponsored by OHSU Knight Cancer Institute, which has 242 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04251715 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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