Study Summary
This trial will study if systemic induction of mFOLFIRINOX, followed by hepatic arterial infusion floxuridine-dexamethasone administered concurrently with systemic mFOLFIRI can effectively and safely treat patients with liver-dominant ICC that cannot be removed by surgery.
- Unresectable Intrahepatic Cholangiocarcinoma
- Liver Cancer
- Stage III Intrahepatic Cholangiocarcinoma
- Intrahepatic Cholangiocarcinoma
- Stage IV Intrahepatic Cholangiocarcinoma
- Stage IIIB Intrahepatic Cholangiocarcinoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 8 Secondary · Reporting Duration: Up to 2 years
Trial Safety
Safety Progress
Side Effects for
Trial Design
1 Treatment Group
mFOLFIRINOX, Floxuridine-DEX, mFOLFIRI
1 of 1
Experimental Treatment
30 Total Participants · 1 Treatment Group
Primary Treatment: Floxuridine · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 20 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Dindo, Daniel, Nicolas Demartines, and Pierre-Alain Clavien. 2004. “Classification of Surgical Complications”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.sla.0000133083.54934.ae.
- Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Skye C Mayo 2021. "mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04251715.
Frequently Asked Questions
Has Floxuridine been tested in any prior experiments?
"At present, 1083 trials for Floxuridine are underway with 303 of those being Phase 3 studies. These experiments mainly centre around Guangzhou in the province of Guangdong yet research is taking place at 38344 different locations worldwide." - Anonymous Online Contributor
How many participants are enrolled in the trial?
"Correct. The details found on clinicaltrials.gov show that recruitment for this medical trial, which was originally posted in April 2021, is ongoing and searching for 30 participants at a single site." - Anonymous Online Contributor
To what conditions is Floxuridine typically prescribed?
"Floxuridine can be employed to treat ocular conditions such as neoplasm metastasis, ophthalmia, sympathetic nerve affection and branch retinal vein occlusion." - Anonymous Online Contributor
Has Floxuridine been granted authorization by the FDA?
"Due to the Phase 2 clinical trial status of Floxuridine, our team at Power has given its safety a score of 2. This implies that some evidence exists for its security yet none is present to back up claims about efficacy." - Anonymous Online Contributor
Are there any openings for participation in this experiment?
"According to clinicaltrials.gov, this research study is currently in search of participants. It initially was published on April 28th 2021 and the most recent changes were made October 11th 2022." - Anonymous Online Contributor