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.
For more information about who can join this study, please contact the study team at Melissa.Rodgman@duke.edu.
What is Involved?
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)
There is an equal, 50/50 chance of being assigned to either group.
You will continue to receive the study drugs for as long as you choose if the study doctor finds that you are getting a positive benefit from them.
- 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)
There is an equal, 50/50 chance of being assigned to either group.
You will continue to receive the study drugs for as long as you choose if the study doctor finds that you are getting a positive benefit from them.
Study Details
Principal Investigator
Michael
Lidsky
Protocol Number
PRO00105078
NCT ID
NCT04891289
Phase
II
Enrollment Status
OPEN TO ACCRUAL