New combo therapy aims to buy more time for bile duct cancer patients
NCT ID NCT04891289
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 164 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2021
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
8 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Duke University (Data Collection Only)
ACTIVE_NOT_RECRUITINGDurham, North Carolina, 27710, United States
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Erasmus University (Data Collection Only)
RECRUITINGRotterdam, 3015 GD, Netherlands
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Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen - Limited Protocol Activities
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Commack - Limited Protocol Activities
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth - Limited Protocol Activities
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau - Limited Protocol Activities
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester - Limited Protocol Activities
RECRUITINGHarrison, New York, 10604, United States
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National Heart, Lung, and Blood Institute (NIH) (Data Collection Only)
ACTIVE_NOT_RECRUITINGBethesda, Maryland, 20824, United States
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Washington University (Data Collection Only)
ACTIVE_NOT_RECRUITINGSt Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bile may hold the key to guiding targeted treatment for bile duct and gallbladder cancers
- Freezing tumors plus dual immunotherapy: a new attack on bile duct cancer
- Can Re-Assessing bile duct cancer treatment open the door to surgery?
- Radiation beads plus immunotherapy: a new way to attack liver cancer?
- Can sound waves supercharge immunotherapy against bile duct cancer?
- Can blood tests reveal how liver and bile duct cancers respond to treatment?