NCT04891289

Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery

A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR/Dexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the safety and effects of HAI floxuridine and dexamethasone combined with the standard chemotherapy drugs gemcitabine and oxaliplatin (GemOx) with those of GemOx alone in people with untreated cholangiocarcinoma that cannot be removed with surgery. The researchers want to find out whether the study treatment works better than the standard chemotherapy to delay progression of disease. For the study treatment to be considered better than the standard treatment, the study treatment should increase the time until progression of disease by an average of 3 months, compared with the usual approach.

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	See arm for details.
DRUG	Oxaliplatin	See arm for details.
DRUG	Dexamethasone	See arm for details.
DRUG	Floxuridine (FUDR)	See arm for details.
DEVICE	Implanted Medical Device	Implanted hepatic arterial infusion pump by surgical oncology, to deliver HAI therapy

Timeline

• Start date: 2021-05-07
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2021-05-18
• Last updated: 2026-04-01

Locations

11 sites across 2 countries: United States, Netherlands

Regulatory

• FDA-regulated drug study
• FDA-regulated device study