NCT06313203View on ClinicalTrials.gov

HAI-Floxuridine, or SIRT, Combined with Gemox for Patients with Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

February 13, 2024

Primary Completion Date

January 31, 2031

Study Completion Date

January 31, 2034

Conditions
Intrahepatic CholangiocarcinomaChemotherapy Effect
Interventions
DRUG

Floxuridine

A laparotomy will be performed and a catheter placed in the hepatic artery Connected to a subcutaneous pump. This pump will be percutaneously filled with Floxuridine 6 times in 2 weeks cycles, alternating with heparin-solution. The patients in this arm will also be given GemOX as systemic chemotherapy

PROCEDURE

Selective Internal Radiation Therapy (SIRT)

Radioactive Yttrium 90 (Y-90) labeled particles are injected selectively into the feeding arteries of the tumour(s). This allows a high radiation dose in the lesions while limiting systemic side effects.

Trial Locations (1)

0424

Oslo University Hospital, Oslo

All Listed Sponsors
lead

Oslo University Hospital

OTHER

NCT06313203 - HAI-Floxuridine, or SIRT, Combined with Gemox for Patients with Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT) | Biotech Hunter | Biotech Hunter