Purpose of this Study
We are doing this study to find out whether hepatic artery infusion (HAI) pump therapy with floxuridine and dexamethasone is an effective treatment for cholangiocarcinoma that cannot be removed with surgery and has not been treated yet. We want to find out whether the HAI pump treatment plus GemOx chemotherapy works as well as or better than GemOx alone at extending the time before your disease gets worse.
Who Can Participate?
Eligibility
Adults who have cholangiocarcinoma (cancer in the small tubes that carry bile through the liver) that has not been treated and cannot be removed with surgery (unresectable).
For more information about who can join this study, please contact the study team at Melissa.Rodgman@duke.edu.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will be randomly assigned (like a coin flip) to 1 of 2 groups:
- Participants in Group 1 will have a Hepatic Artery Infusion (HAI) pump placed by surgery and receive chemotherapy through the pump
- Participants in Group 2 will receive only chemotherapy by infusion into your vein (IV)
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Randomized Phase II Study of Systemic Chemotherapy with or without Hai Fudr/Dexamethasone in Patients with Unresectable Intrahepatic Cholangiocarcinoma
Principal Investigator
Michael
Lidsky
Protocol Number
PRO00105078
NCT ID
NCT04891289
Phase
II
Enrollment Status
Open to Enrollment