Study of Hepatic Arterial Infusion to Treat Biliary Tract Carcinomas

Peking University

Status and phase

Completed

Phase 2

Conditions

Biliary Tract Cancer

Treatments

Drug: Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT01572324

PUCH12031308

Details and patient eligibility

About

This Phase II clinical trial is to study the effectiveness and safety of continuous hepatic arterial infusion (HAI) of Oxaliplatin and Fluorouracil in Patients with Unresectable Biliary tract carcinomas, and to explore a better first-line treatment regimen for these patients.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient must have histologically or cytologically confirmed Biliary tract carcinomas including intrahepatic, hilar cholangiocarcinoma and gallbladder cancer without evident 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 document

Exclusion criteria

Patients who have had prior chemotherapy and other antitumor therapy treatment
Patient who is receiving any other investigational agents
Patient who have evident distant (M) disease;
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 requirements
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 therapy)