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ACTIVE NOT RECRUITING
NCT04251715
PHASE2

mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma

Sponsor: OHSU Knight Cancer Institute

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2021-04-28

Completion Date

2025-11-30

Last Updated

2025-04-18

Healthy Volunteers

No

Interventions

DRUG

Dexamethasone

Given intraarterially via HAI pump

DRUG

Floxuridine

Given intraarterially via HAI pump

DEVICE

Implanted Medical Device

Implanted hepatic arterial infusion pump by surgical oncology, to deliver HAI therapy

DRUG

Irinotecan

Given IV

DRUG

Leucovorin

Given IV

DRUG

Oxaliplatin

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

Locations (1)

OHSU Knight Cancer Institute

Portland, Oregon, United States