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Gemcitabine and Oxaliplatin with or without Floxuridine and Dexamethasone for Cholangiocarcinoma

This study is for people with cholangiocarcinoma (a type of cancer that forms in the bile ducts) that cannot be removed with surgery. It compares two treatment approaches. One group will receive standard chemotherapy with gemcitabine and oxaliplatin (GemOx). The other group will receive GemOx plus floxuridine and dexamethasone delivered through an implanted pump directly to the liver. Researchers want to see if adding the pump-delivered drugs helps delay the cancer from growing or spreading for at least 3 months longer than GemOx alone. You may be able to join if you are at least 18 years old and have intrahepatic cholangiocarcinoma. The study aims to enroll 164 participants, but its current status is unclear.

Study design
This is an interventional study comparing two treatment groups. It plans to enroll 164 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will assess how long it takes for the disease to progress, measured at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04891289

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~164 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:GemcitabineOxaliplatinDexamethasoneFloxuridine (FUDR)Implanted Medical Device

At a glance

Recruiting sites
8 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
assess progression-free survival (PFS)
Measured over 2 years

Conditions

Intrahepatic Cholangiocarcinoma

Explore related trials

Intrahepatic Cholangiocarcinoma

NCT04891289

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Erasmus University (Data Collection Only)

    Rotterdam, Netherlandsstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities

    Basking Ridge, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Bergen - Limited Protocol Activities

    Montvale, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Commack - Limited Protocol Activities

    Commack, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Monmouth - Limited Protocol Activities

    Middletown, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Nassau - Limited Protocol Activities

    Uniondale, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Westchester - Limited Protocol Activities

    Harrison, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Andrea Cercek, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Andrea Cercek, MD
[email protected]
646-888-4189
Email the study team

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Eligibility criteria

Inclusion

Age ≥18 years
ECOG 0-1
Histologically confirmed intrahepatic cholangiocarcinoma (also variously reported as peripheral cholangiocarcinoma, cholangiolar carcinoma or cholangiocellular carcinoma) (IHC). Confirmation of the diagnosis at MSKCC or at the enrolling institution must be obtained prior to randomization.
Clinical or radiographic evidence of metastatic disease confined to the liver. Note: presence of regional (porta hepatis) lymph node metastases will be allowed, provided they are amenable to resection. (Note: If peritoneal or other extrahepatic disease is found at time of pump placement, the pump will not be implanted. The patient will be removed from study, deemed nonevaluable and will not count toward the overall study accrual.)
Radiographically measurable disease. Measurable disease is defined as disease that can be assessed with 2-dimensional measurements on a cross-sectional imaging. Minimum lesion size is 2 cm in greatest diameter as per RECIST criteria.
Disease must be considered unresectable at the time of preoperative evaluation.\*
Considered candidate for general anesthesia, abdominal exploration and hepatic artery pump placement.
Patients with chronic hepatitis and/or cirrhosis are eligible, but must be Child-Pugh class A.
WBC ≥ 2,000/mcL , ANC ≥ 1000/mcL
Platelet count ≥ 75,000/mcL
Creatinine ≤ 1.8 mg/dL
Total bilirubin \< 1.5 mg/dL
Hgb \> 7 g/dL The % involvement of the liver will be determined by radiologists after review of imaging

Exclusion

Presence of distant metastatic disease. Patients will undergo radiographic evaluation to exclude the possibility of distant metastatic disease. For patients who have undergone pre- or post-operative biopsies that definitively diagnose IHC, the diagnostic studies may be modified at the discretion of the MSKCC Principal Investigator. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection.
Patients previously treated with systemic chemotherapy for IHC will be non-eligible.
Prior treatment with FUDR.
Prior external beam radiation therapy to the liver.
Prior ablative therapy to the liver.
Diagnosis of sclerosing cholangitis.
Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis; surgically related ascites does not exclude the patient).
Active infection within one week prior to HAI placement.
Pregnant or lactating women.
History of other malignancy within the past 3 years except with early stage/localized cancer that was surgically resected or radiation treatment that would yield the same result as surgery within the past 3 years.
Life expectancy \<12 weeks.
Inability to comply with study and/or follow-up procedures.
History of peripheral neuropathy. There is no exclusion of patients based on sex, ethnicity or race. For these reasons, the study results are expected to be generalizable to the Medicare beneficiary population.

What this trial measures

  • assess progression-free survival (PFS)2 years

    will be done using RECIST (version 1.1).