Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

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

NCT04891289 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Oxaliplatin
  • DRUG Dexamethasone
  • DRUG Gemcitabine
  • DRUG Floxuridine (FUDR)
  • DEVICE Implanted Medical Device

Study Locations (11)

New York

  • Memorial Sloan Kettering Commack - Limited Protocol Activities — Commack
  • Memorial Sloan Kettering Westchester - Limited Protocol Activities — Harrison
  • Memorial Sloan Kettering Cancer Center — New York
  • Memorial Sloan Kettering Nassau - Limited Protocol Activities — Uniondale

New Jersey

  • Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities — Basking Ridge
  • Memorial Sloan Kettering Monmouth - Limited Protocol Activities — Middletown
  • Memorial Sloan Kettering Bergen - Limited Protocol Activities — Montvale

Maryland

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

Missouri

  • Washington University (Data Collection Only) — St Louis

North Carolina

  • Duke University (Data Collection Only) — Durham

Other

  • Erasmus University (Data Collection Only) — Rotterdam

Trial Details

FieldValue
Enrollment Target 164 participants
Start Date 2021-05-07
Est. Completion 2026-05
Phase Phase 2

Sponsor

Memorial Sloan Kettering Cancer Center

2,280 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04891289

The ClinicalTrials.gov registry entry for NCT04891289 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 2,280 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Intrahepatic Cholangiocarcinoma appearing as the primary indexed condition, and to 5 interventions — of which Oxaliplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04891289 reports 11 study locations spanning 6 distinct geographic areas — top geographies include New York, New Jersey, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04891289 about?

NCT04891289 is a clinical study titled "Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery". 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 fin...

What is the current status of trial NCT04891289?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 164 participants. The study started on 2021-05-07. Estimated completion is 2026-05.

What conditions does trial NCT04891289 study?

This clinical trial studies the following conditions: Intrahepatic Cholangiocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04891289?

The interventions under investigation include: Oxaliplatin (DRUG), Dexamethasone (DRUG), Gemcitabine (DRUG), Floxuridine (FUDR) (DRUG), Implanted Medical Device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04891289?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 2,280 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04891289 being conducted?

This trial has 11 study locations across Maryland, Missouri, New Jersey, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial