Double-Barreled chemo attack on bile duct cancer shows promise
NCT ID NCT01862315
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests a two-pronged chemotherapy approach for people with intrahepatic cholangiocarcinoma (a type of bile duct cancer) that cannot be removed by surgery. Participants receive chemotherapy directly to the liver through a surgically placed pump, plus standard chemotherapy through a vein to treat the whole body. The goal is to see if this combination improves tumor shrinkage and delays cancer spread. The trial also explores whether special MRI scans can help predict treatment response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- floxuridine, dexamethasone, gemcitabine, oxaliplatin
- What this could lead to
- If successful, this combination approach could offer a more effective treatment option for people with bile duct cancer that cannot be surgically removed.
- What could go wrong
- This is a mid-stage trial with a small number of participants, so results may not apply to everyone. The treatment involves surgery to place a pump and carries risks like infection or liver damage.
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
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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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56 people
The number who actually took part.
- Start date
-
May 2013
- Finished
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Mar 2025
- 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
-
21 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 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 ≥ 21 years * Histologically confirmed intrahepatic cholangiocarcinoma (also variously reported as peripheral cholangiocarcinoma, cholangiolar carcinoma or cholangiocellular carcinoma) (ICC). Confirmation of the diagnosis at MSKCC or at the enrolling institution must be obtained prior to initiation of protocol therapy. * Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection. * 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 2cm in greatest diameter as per RECIST criteria. * Disease must be considered unresectable at the time of preoperative evaluation. * Presence of less than 70% liver involvement by cancer. * Patients may have failed ablative therapy * Patient previously treated with systemic chemotherapy will be eligible * KPS ≥ 60% and be considered candidates 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 * Patients must be able to read, understand and sign informed consent * WBC ≥ 2,000 cells/mm3 * Platelet count ≥ 75,000/mm3 * Creatinine ≤ 1.8 mg/dl * Total bilirubin \< 1.5 mg/dl 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 postoperative biopsies that definitively diagnose ICC, 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. * Prior treatment with FUDR * Prior external beam radiation 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 * Pregnant or lactating women * History of other malignancy within the past 3 years (except non-melanoma skin cancer) * Life expectancy less than 12 weeks * Inability to comply with study and/or followup procedures * History of peripheral neuropathy (Note: this does not apply to Cohort 3)
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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.
Contacts and locations
Locations
-
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
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Other studies related to the condition(s) this trial covers.
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- Can matching drugs to tumor genes beat biliary cancer?