Actively Recruiting
Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-22
164
Participants Needed
11
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status 0 or 1
- Histologically confirmed intrahepatic cholangiocarcinoma
- Metastatic disease confined to the liver, with regional lymph node metastases allowed if resectable
- Radiographically measurable disease with lesion size at least 2 cm
- Disease considered unresectable at preoperative evaluation
- Candidate for general anesthesia, abdominal exploration, and hepatic artery pump placement
- Chronic hepatitis or cirrhosis allowed if Child-Pugh class A
- White blood cell count at least 2,000/mcL
- Absolute neutrophil count at least 1,000/mcL
- Platelet count at least 75,000/mcL
- Creatinine 1.8 mg/dL or less
- Total bilirubin less than 1.5 mg/dL
- Hemoglobin greater than 7 g/dL
You will not qualify if you...
- Presence of distant metastatic disease
- Prior systemic chemotherapy for intrahepatic cholangiocarcinoma
- Prior treatment with floxuridine (FUDR)
- Prior external beam radiation therapy to the liver
- Prior ablative therapy to the liver
- Diagnosis of sclerosing cholangitis
- Clinical evidence of portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis)
- Active infection within one week before hepatic arterial infusion pump placement
- Pregnant or lactating women
- History of other malignancy within the past 3 years except early stage/localized cancer treated with surgery or radiation
- Life expectancy less than 12 weeks
- Inability to comply with study and follow-up procedures
- History of peripheral neuropathy
AI-Screening
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Trial Site Locations
Total: 11 locations
1
National Heart, Lung, and Blood Institute (NIH) (Data Collection Only)
Bethesda, Maryland, United States, 20824
Actively Recruiting
2
Washington University (Data Collection Only)
St Louis, Missouri, United States, 63110
Actively Recruiting
3
Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
4
Memorial Sloan Kettering Monmouth - Limited Protocol Activities
Middletown, New Jersey, United States, 07748
Actively Recruiting
5
Memorial Sloan Kettering Bergen - Limited Protocol Activities
Montvale, New Jersey, United States, 07645
Actively Recruiting
6
Memorial Sloan Kettering Commack - Limited Protocol Activities
Commack, New York, United States, 11725
Actively Recruiting
7
Memorial Sloan Kettering Westchester - Limited Protocol Activities
Harrison, New York, United States, 10604
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
9
Memorial Sloan Kettering Nassau - Limited Protocol Activities
Uniondale, New York, United States, 11553
Actively Recruiting
10
Duke University (Data Collection Only)
Durham, North Carolina, United States, 27710
Actively Recruiting
11
Erasmus University (Data Collection Only)
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
Research Team
A
Andrea Cercek, MD
CONTACT
W
William Jarnagin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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