Study Stopped
change in standard-of-care systemic therapy
mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma
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
Other study identifiers
Sponsor study identifier
Secondary identifiers
REGISTRY · CTRP (Clinical Trial Reporting Program)
OTHER · OHSU Knight Cancer Institute
OTHER · OHSU Knight Cancer Institute
interventional
5
1 country
1
Study Start
April 28, 2021
Actual (reported)Primary Completion
March 20, 2024
Actual (reported)Study Completion
March 20, 2024
Actual (reported)Brief 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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- terminated
- Actual enrollment (reported)
- 5 participants
- Study completion date
March 20, 2024
Actual (reported)- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
January 30, 2020
Actual (reported)First Posted
February 5, 2020
Actual (reported)Study Start
April 28, 2021
Actual (reported)Primary Completion
March 20, 2024
Actual (reported)Study Completion
March 20, 2024
Actual (reported)Results Posted
June 25, 2026
Actual (reported)
- Last Updated
- June 25, 2026
- Status Verified
- May 2026
- Results QC Date
- May 29, 2026
- Last Update Submitted
- May 29, 2026