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Chemotherapy with or without a pump for inoperable cholangiocarcinoma

A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR/Dexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma

Phase 2 Interventional Memorial Sloan Kettering Cancer Center · NCT04891289

This study is testing if adding a special pump treatment to standard chemotherapy can help people with inoperable cholangiocarcinoma live longer without their cancer getting worse.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment164 (estimated)
Ages18 Years and up
SexAll
SponsorMemorial Sloan Kettering Cancer Center Academic / other
Drugs / interventionschemotherapy, radiation
Locations11 sites (Bethesda, Maryland and 10 other locations)
Trial IDNCT04891289 on ClinicalTrials.gov

What this trial studies

This study compares the safety and effectiveness of a combination treatment involving a pump delivering floxuridine and dexamethasone alongside standard chemotherapy drugs gemcitabine and oxaliplatin, against the standard chemotherapy alone in patients with untreated intrahepatic cholangiocarcinoma that cannot be surgically removed. The goal is to determine if the combination treatment can delay disease progression by an average of three months compared to standard treatment. Participants will be monitored for their response to the treatment and any side effects experienced.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed intrahepatic cholangiocarcinoma and measurable disease confined to the liver.

Not a fit: Patients with extrahepatic disease or those who do not meet the inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a significant delay in disease progression for patients with inoperable cholangiocarcinoma.

How similar studies have performed: Other studies have explored similar chemotherapy combinations, but this specific approach with the pump is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Bethesda, Maryland and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Intrahepatic CholangiocarcinomaGemcitabineOxaliplatinFloxuridineDexamethasone Pump20-348
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.