RecruitingPhase 2NCT04891289

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

164 participants

Start Date

May 7, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two chemotherapy approaches for patients with a type of bile duct cancer (intrahepatic cholangiocarcinoma) that has not spread beyond the liver but cannot be surgically removed. One group receives standard chemotherapy (gemcitabine + oxaliplatin); the other also receives a pump placed in a liver artery to deliver an additional drug (floxuridine) directly to the liver. **You may be eligible if...** - You are 18 or older with confirmed intrahepatic cholangiocarcinoma (a type of bile duct cancer) - Your cancer is confined to the liver (or nearby lymph nodes that can be removed) - Your cancer cannot be surgically removed at this time - You have measurable disease and adequate organ function - You are a candidate for general anesthesia and a surgical pump placement procedure **You may NOT be eligible if...** - Your cancer has spread outside the liver to distant organs - You have previously received chemotherapy for this cancer or prior liver radiation or ablation - You have portal hypertension (fluid in the abdomen or varicose veins in the esophagus) - You are pregnant or breastfeeding - You have peripheral neuropathy (nerve damage) or a life expectancy under 12 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGemcitabine

See arm for details.

DRUGOxaliplatin

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DRUGDexamethasone

See arm for details.

DRUGFloxuridine (FUDR)

See arm for details.

DEVICEImplanted Medical Device

Implanted hepatic arterial infusion pump by surgical oncology, to deliver HAI therapy


Locations(11)

National Heart, Lung, and Blood Institute (NIH) (Data Collection Only)

Bethesda, Maryland, United States

Washington University (Data Collection Only)

St Louis, Missouri, United States

Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth - Limited Protocol Activities

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen - Limited Protocol Activities

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack - Limited Protocol Activities

Commack, New York, United States

Memorial Sloan Kettering Westchester - Limited Protocol Activities

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau - Limited Protocol Activities

Uniondale, New York, United States

Duke University (Data Collection Only)

Durham, North Carolina, United States

Erasmus University (Data Collection Only)

Rotterdam, Netherlands

View Full Details on ClinicalTrials.gov

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NCT04891289


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