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Phase II Study of Hepatic Arterial Infusion With Oxaliplatin and Fluorouracil in Patients With Unresectable Biliary Tract Carcinomas

Phase 2
18 Years
Open (Enrolling)
Biliary Tract Cancer

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Trial Information

Phase II Study of Hepatic Arterial Infusion With Oxaliplatin and Fluorouracil in Patients With Unresectable Biliary Tract Carcinomas

Inclusion Criteria:

- Patient must have histologically or cytologically confirmed Biliary tract carcinomas
including intrahepatic, hilar cholangiocarcinoma and gallbladder cancer with or
without liver metastasis.

- Patient must have locally advanced disease that is unresectable after review by the
Hepatobiliary Surgery service

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

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Hemoglobin >= 90g/L

- Total bilirubin =< 2 X institutional upper limit of normal

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT])
=< 2.5 X institutional upper limit of normality

- Creatinine =< 1.5 X institutional upper limit of normal

- Albumin >= 30g/L

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

Exclusion Criteria:

- Patients who have had prior chemotherapy and other antitumor therapy treatment

- Patient who is receiving any other investigational agents

- Patient who have N2 or distant (M) disease; (patients with limited N1 disease are

- Patient who have a diagnosis of hepatic encephalopathy

- Patients who have a diagnosis of sclerosing cholangitis.

- Patients who have a diagnosis of Gilbert's disease.

- Patients who have clinical ascites

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

- No other malignancy except localized basal cell or squamous cell skin cancer in the
past 5 years

- Patient who is pregnant or lactating

- Patient Allergic to Iodine contrast medium

- Uncontrolled severe coagulation disorders (INR < 1.5 in patients not on warfarin

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progress free survival

Outcome Description:

Describe median PFS with a 95% confidence interval.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Xiaodong Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking University Cancer hospital & Institute


China: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

February 2016

Related Keywords:

  • Biliary Tract Cancer
  • Cholangiocarcinoma
  • gallbladder cancer
  • Infusions
  • Intra-Arterial
  • Carcinoma
  • Biliary Tract Neoplasms