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

Recruiting Phase 2 Interventional Study
Intrahepatic Cholangiocarcinoma Chemotherapy Effect
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
39 (estimated)
Sponsor
Oslo University Hospital · Other
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About This Trial
Patients with intrahepatic cholangiocarcinoma (IHC) have relatively aggressive tumors, and the prognosis for most of these patients is dismal. Surgery is the only option that can offer potential cure, but only an estimated 20-25 % are amenable to resection. Down-staging conventional chemotherapy has a relatively low response rate (\< 50 %). Patients will be included into the respective treatment a…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Intra-hepatic cholangiocarcinoma. Diagnosis confirmed by biopsy, cytology or previous resection. 2. Not amenable for upfront resection. Defined as: 1. A tumour that is technically not resectable with R0 margins (i.e. where resection will not yield an FLR of sufficient siz…
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