Gemcitabine and Oxaliplatin for Intrahepatic Cholangiocarcinoma

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

Recruiting Phase 2 Interventional Study
Intrahepatic Cholangiocarcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
164 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for

This trial is looking for people with a type of cancer called intrahepatic cholangiocarcinoma that cannot be treated with surgery. Participants will receive a specific combination of chemotherapy and possibly a special pump to help treat their cancer.

Are You a Good Fit for This Trial?
Rules you out Sclerosing cholangitisActive infectionOther malignancy within the past 3 yearsPortal hypertension

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with intrahepatic cholangiocarcinoma.
  • I have cancer that is only in my liver.
  • I have measurable cancer that can be seen on scans.
  • My cancer cannot be removed with surgery right now.
  • I can be put under general anesthesia.
  • I have certain blood test results that are within the required range.
  • I have chronic hepatitis or cirrhosis, but it is classified as Child-Pugh class A.

You may not be able to join if

  • I have cancer that has spread to areas outside my liver.
  • I have had chemotherapy for intrahepatic cholangiocarcinoma before.
  • I have received treatment with a specific drug called FUDR.
  • I have had radiation therapy or any type of ablative therapy to my liver.
  • I have been diagnosed with sclerosing cholangitis.
  • I have active infections within a week before starting treatment.
  • I am pregnant or breastfeeding.
  • I have any serious health issues that limit my life expectancy.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 o…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 m…
Contacts

Andrea Cercek, MD

646-888-4189

cerceka@mskcc.org

CONTACT

William Jarnagin, MD

212-639-7601

CONTACT