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
The purpose of this study is to evaluate the efficacy of systemic induction of mFOLFIRINOX, followed by HAI floxuridine-DEX administered concurrently with systemic mFOLFIRI, as measured by disease control rate (DCR) at 6 months and to assess safety of treatment with HAI floxuridine-DEX delivered concurrently with systemic mFOLFIRI.
• Liver-dominant ICC, must comprise <70% of the liver parenchyma, as defined by CT liver segmental volumetrics.
• Disease must be considered technically unresectable or be multifocal in the liver at the time of preoperative evaluation
• ECOG 0 or 1 status (Karnofsky ≥ 60)
• Presence of extensive or multifocal metastatic extrahepatic or peritoneal disease.
• Prior treatment with floxuridine, oxaliplatin, or irinotecan.
• Prior external beam radiation therapy to the liver or hepatic arterial or venous delivery of internal radiation therapy such as Y-90.
• Current biliary obstruction requiring placement of endoscopic or transhepatic stents for biliary decompression.
18 - 100
Healthy Volunteers Needed
Duration of Participation
Approximately 33 weeks + maintenance of the HAI pump
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