BENITIONSClinical Trial Intelligence

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

Фаза 2 Прекращено NCT04251715

ЗаболеваниеLiver and Intrahepatic Bile Duct Carcinoma, Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8
ФазаФаза 2
СпонсорOHSU Knight Cancer Institute
СтатусПрекращено
Участники5 участн.
ВмешательствоDexamethasone, Floxuridine, Implanted Medical Device, Irinotecan, Leucovorin
Дата начала28.04.2021
Дата завершения20.03.2024
Публикация результатов25.06.2026

Кратко

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.

Frequency of Abnormal Liver Function

Up to 6 months after starting HAI with floxuridine · Participants

mFOLFIRINOX Followed by Concurrent HAI-Floxuridine and mFOLFIRI0 Participants

Disease Control Rate (DCR) - During HAI+SYS

Up to 6 months after starting HAI with floxuridine · percentage of participants

mFOLFIRINOX, Floxuridine-DEX, mFOLFIRI100 percentage of participants
mFOLFIRINOX, Floxuridine-DEX, mFOLFIRI0 percentage of participants
mFOLFIRINOX, Floxuridine-DEX, mFOLFIRI100 percentage of participants
mFOLFIRINOX, Floxuridine-DEX, mFOLFIRI0 percentage of participants

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