Floxuridine for Unresectable Intrahepatic Cholangiocarcinoma

Phase-Based Progress Estimates
OHSU Knight Cancer Institute, Portland, ORUnresectable Intrahepatic Cholangiocarcinoma+5 MoreFloxuridine - Drug
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Unresectable Intrahepatic Cholangiocarcinoma
  • Liver Cancer
  • Stage III Intrahepatic Cholangiocarcinoma
  • Intrahepatic Cholangiocarcinoma
  • Stage IV Intrahepatic Cholangiocarcinoma
  • Stage IIIB Intrahepatic Cholangiocarcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Up to 2 years

Up to 1 year
Progression free survival (PFS) - FOLFIRINOX
Proportion of liver toxicity in participants receiving HAI floxuridine + dexamethasone therapy
Up to 2 years
DCR - entire treatment
Disease control rate (DCR) - during HAI+SYS
Incidence of abnormal liver function
Overall response rate (ORR)
Overall survival (OS)
Week 9
Incidence of serious post-operative complications

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Single Arm
31%Grade 3 Fatigue
28%Grade 3 Neutropenia
17%Grade 3 Diarrhea
10%Grade 4 Neutropenia
10%Grade 3 Febrile Neutropenia
3%Grade 3 Nausea
3%Grade 3Thrombocytopenia
3%Grade 3 Deep Venous Thrombosis
This histogram enumerates side effects from a completed 2010 Phase 2 trial (NCT00448760) in the Single Arm ARM group. Side effects include: Grade 3 Fatigue with 31%, Grade 3 Neutropenia with 28%, Grade 3 Diarrhea with 17%, Grade 4 Neutropenia with 10%, Grade 3 Febrile Neutropenia with 10%.

Trial Design

1 Treatment Group

1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Floxuridine · No Placebo Group · Phase 2

mFOLFIRINOX, Floxuridine-DEX, mFOLFIRIExperimental Group · 7 Interventions: Dexamethasone, Quality-of-Life Assessment, Oxaliplatin, Irinotecan, Leucovorin, Implanted Medical Device, Floxuridine · Intervention Types: Drug, Other, Drug, Drug, Drug, Device, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
FDA approved
FDA approved
FDA approved
Implanted Medical Device
Completed Early Phase 1
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
211 Previous Clinical Trials
2,089,500 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
903 Previous Clinical Trials
6,830,591 Total Patients Enrolled
Skye C Mayo, MD, MPHPrincipal Investigator - OHSU Knight Cancer Institute
OHSU Knight Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 20 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The cancer has spread to nearby lymph nodes and possibly to the lungs, but the principal investigator may allow participation.
Your intrahepatic cholangiocarcinoma (ICC) cannot be removed by surgery or is considered too risky to operate on because it has spread in the liver or is in multiple places.

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.