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Protocol Details

A Randomized Phase II Study of Systemic Chemotherapy with or without HAI FUDR-Dexamethasone in Patients with Unresectable Intrahepatic Cholangiocarcinoma

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)

Pregnant Women;


Hepatic Arterial Infusion Pump;
Progression Free Survival;
Response Rates;
Patient Survival

Recruitment Keyword(s)



Intrahepatic Cholangiocarcinoma (Ihc);
Peripheral Cholangiocarcinoma;
Cholangiolar Carcinoma;
Cholangiocellular Carcinoma;
Bile Duct Neoplasms;
Bile Duct Cancer;
Liver Neoplasms;
Liver Cancer

Investigational Drug(s)


Investigational Device(s)

Intera 3000 Pump


Device: Intera 3000 Pump
Drug: Oxaliplatin
Drug: Gemcitabine
Drug: Floxuridine
Drug: Dexamethasone

Supporting Site

National Cancer Institute


Intrahepatic cholangiocarcinoma (IHC) is cancer of the small tubes that carry bile through the liver. Surgery is the best way to treat IHC; however, surgical removal is not an option if the disease is not diagnosed early enough. People with IHC that cannot be treated with surgery typically survive less than 12 months. Better treatments are needed.


To test a new hepatic arterial infusion (HAI) pump therapy, combined with standard chemotherapy, in people with advanced IHC.


People aged 18 years and older with untreated IHC that cannot be removed with surgery.


Participants will be screened. They will have blood tests. They will have a test of their heart function. A surgeon will remove tissue samples of their liver through a small incision.

Participants will be assigned randomly to 1 of 2 study groups.

The first group will have surgery to place an HAI pump in the abdomen. On the first day of each 28-day treatment cycle, the pump will be filled with two drugs (floxuridine and dexamethasone). These drugs will be delivered continuously to the liver over 14 days. On day 15, the pump will be emptied, cleaned, and filled with saline solution.

Participants in both groups will receive treatment with approved chemotherapy drugs GemOx (gemcitabine and oxaliplatin). They will come to the clinic once every 2 weeks to receive GemOx. The drugs are delivered through a needle placed in the arm.

Participants will have blood tests and CT scans throughout the study.

Participants may remain in the study as long as they are benefiting from treatment.

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Participant 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

* Unresectability will be determined by experienced HPB surgeons after review of cross-sectional imaging studies. Unresectability may be due to multifocal liver disease, the presence of metastatic disease to regional lymph nodes or locally advanced disease with extensive involvement of major inflow hepatic pedicles and/or hepatic venous drainage.

The % involvement of the liver will be determined by radiologists after review of imaging

Participant 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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Not Provided

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Principal Investigator

Referral Contact

For more information:

Jonathan M. Hernandez, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-3740
(240) 760-6072

Cathleen E. Hannah, C.R.N.P.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-5740
(240) 858-7006

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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