mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma
2상
조기 종료
NCT04251715
| 대상 질환 | Liver and Intrahepatic Bile Duct Carcinoma, Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8 |
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| 임상 단계 | 2상 |
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| 스폰서 | OHSU Knight Cancer Institute |
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| 상태 | 조기 종료 |
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| 참여자 수 | 5 명 |
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| 중재(약물) | Dexamethasone, Floxuridine, Implanted Medical Device, Irinotecan, Leucovorin |
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| 시작일 | 2021년 4월 28일 |
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| 완료일 | 2024년 3월 20일 |
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| 결과 공개일 | 2026년 6월 25일 |
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요약
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 mFOLFIRI | 0 Participants |
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Disease Control Rate (DCR) - During HAI+SYS
Up to 6 months after starting HAI with floxuridine · percentage of participants
| mFOLFIRINOX, Floxuridine-DEX, mFOLFIRI | 100 percentage of participants |
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| mFOLFIRINOX, Floxuridine-DEX, mFOLFIRI | 0 percentage of participants |
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| mFOLFIRINOX, Floxuridine-DEX, mFOLFIRI | 100 percentage of participants |
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| mFOLFIRINOX, Floxuridine-DEX, mFOLFIRI | 0 percentage of participants |
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