Open for Enrollment Soon
This study will open for enrollment soon. Please contact the study team for more information and check back frequently.

Phase 2 Chemo with or without Hepatic Artery Infusion for IHCC (Cholangiocarcinoma) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Cholangiocarcinoma

Who Can Participate in the Study?

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 Group
Adults

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.

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
Gastrointestinal Surgeon
Protocol Number
IRB: PRO00105078
NCT: NCT04891289
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon
More Information
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698