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Pilot Study of Hepatic Arterial Infusion Therapy in Patients With Unresectable or Borderline Resectable Intrahepatic Cholangiocarcinoma

Phase 0
18 Years
Open (Enrolling)
Cholangiocarcinoma, Liver Neoplasms

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Trial Information

Pilot Study of Hepatic Arterial Infusion Therapy in Patients With Unresectable or Borderline Resectable Intrahepatic Cholangiocarcinoma

Inclusion Criteria:

- Patient must have histologically or cytologically confirmed intrahepatic or hilar
cholangiocarcinoma with minimal extrahepatic disease

- Patient must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as >=
20 mm with conventional techniques or as >= 10 mm with spiral computed tomography
(CT) scan/MRI

- Patient must have disease that is unresectable or borderline resectable with < 70%
liver involvement by cancer

- Patient must be >= 18 years old.

- Patient's Eastern Cooperative Oncology Group (ECOG) performance status must be =< 2
(Karnofsky >= 60%)

- Patient must have normal organ and marrow function as defined below:

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 75,000/mcL

- Total bilirubin =< 2 mg/dL

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT])
=< 5 X institutional upper limit of normal

- Creatinine within normal institutional limits

- Patient must be able to understand and willing to sign a written informed consent

Exclusion Criteria:

- Patients must not have had prior treatment with FUDR

- Patient must not be receiving any other investigational agents

- Patient must not have a diagnosis of Gilbert's disease

- Patient must not have a diagnosis of hepatic encephalopathy

- Patient must not have had prior external beam radiation to the liver

- Patient must not have a diagnosis of sclerosing cholangitis

- Patient must not have any uncontrolled intercurrent illness including, but not
limited to, ongoing or active infection, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements

- Patient must not be pregnant or breastfeeding

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity of HAI alone or in combination with systemic oxaliplatin and/or gemcitabine

Outcome Description:

Document the frequency of grades 3-5 non-hematologic toxicities (dose-limiting toxicities) associated with the treatment regimen by patient and by type of toxicity for each cohort.

Outcome Time Frame:

From first receiving study treatment until a 30-day follow up after the conclusion of treatment or death

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

April 2012

Completion Date:

April 2016

Related Keywords:

  • Cholangiocarcinoma
  • Liver Neoplasms
  • Neoplasms
  • Liver Neoplasms
  • Cholangiocarcinoma



Washington University School of Medicine Saint Louis, Missouri  63110