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New combo therapy aims to buy more time for bile duct cancer patients

NCT ID NCT04891289

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This study compares standard chemotherapy (gemcitabine and oxaliplatin) alone versus the same drugs plus a liver-directed chemotherapy (HAI FUDR/dexamethasone) in people with bile duct cancer that has spread within the liver but cannot be removed surgically. About 164 adults with untreated disease will take part. The goal is to see if adding the liver-directed treatment delays cancer growth by at least 3 months on average.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 164 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Duke University (Data Collection Only)

    ACTIVE_NOT_RECRUITING

    Durham, North Carolina, 27710, United States

  • Erasmus University (Data Collection Only)

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen - Limited Protocol Activities

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack - Limited Protocol Activities

    RECRUITING

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth - Limited Protocol Activities

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau - Limited Protocol Activities

    RECRUITING

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester - Limited Protocol Activities

    RECRUITING

    Harrison, New York, 10604, United States

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

    ACTIVE_NOT_RECRUITING

    Bethesda, Maryland, 20824, United States

  • Washington University (Data Collection Only)

    ACTIVE_NOT_RECRUITING

    St Louis, Missouri, 63110, United States

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