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COMPLETED Phase 1

Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma

NCT01938729 · View on ClinicalTrials.gov ↗

Study Summary

This is a Phase I study, which means we want to find out what effects, good and/or bad, this combination of drugs may have on the patient and the liver cancer at different dose levels. All patients will have an operation to remove tumors in the liver and may have a pump placed in their abdomen. On this study, both drugs given have been used in other patients for treatment of cholangiocarcinoma and other gastrointestinal cancers. Both drugs are approved by the food and drug administration (FDA) for treatment of liver cancer, but the two drugs have only been combined in a few patients. That means that in this trial we also want to find out if this combination is safe. The study will also evaluate if this treatment works in delaying or stopping the cancer from coming back after surgery.

Interventions

  • PROCEDURE Liver resection and placement of hepatic artery infusion pump
  • DRUG FLOXURIDINE
  • DRUG DEXAMETHASONE
  • DRUG GEMCITABINE

Study Locations (5)

New York

  • Memorial Sloan Kettering Cancer Center at Commack — Commack
  • Memorial Sloan Kettering Cancer Center — New York
  • Memorial Sloan Kettering Cancer Center at Mercy Medical Center — Rockville Centre
  • Memorial Sloan Kettering Cancer Center Sleepy Hollow — Sleepy Hollow

New Jersey

  • Memorial Sloan Kettering Cancer Center at Basking Ridge — Basking Ridge

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2013-09-05
Est. Completion 2020-09-10
Phase Phase 1

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 NCT01938729

The ClinicalTrials.gov registry entry for NCT01938729 describes a study currently listed as completed. It is categorized as Phase 1, 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 8 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 4 conditions, with Intrahepatic Cholangiocarcinoma appearing as the primary indexed condition, and to 4 interventions — of which Liver resection and placement of hepatic artery infusion pump 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: NCT01938729 reports 5 study locations spanning 2 distinct geographic areas — top geographies include New York, New Jersey. 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 NCT01938729 about?

NCT01938729 is a clinical study titled "Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma". This is a Phase I study, which means we want to find out what effects, good and/or bad, this combination of drugs may have on the patient and the liver cancer at different dose levels. All patients will have an operation to remove tumors in the liver and may have a pump placed in their abdomen. On ...

What is the current status of trial NCT01938729?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2013-09-05. Estimated completion is 2020-09-10.

What conditions does trial NCT01938729 study?

This clinical trial studies the following conditions: Intrahepatic Cholangiocarcinoma, Peripheral Cholangiocarcinoma, Cholangiolar Carcinoma, Cholangiocellular Carcinoma) (ICC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01938729?

The interventions under investigation include: Liver resection and placement of hepatic artery infusion pump (PROCEDURE), FLOXURIDINE (DRUG), DEXAMETHASONE (DRUG), GEMCITABINE (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01938729?

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 NCT01938729 being conducted?

This trial has 5 study locations across New Jersey, New York. 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