Unresectable cholangiocarcinoma
Conditions
Interventions
Patients receive hepatic arterial infusion of gemcitabine via an indwelling catheter and port system at day 1,8, and 15. Treatment repeats every 4 weeks for 5 courses in the absence of disease progre
Sponsors
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Unresectable or survival-limiting intrahepatic cholangiocarcinoma with histologic confirmation. 2) No prior administration of gemcitabine, and no influence of previous treatments. 3) Measurable lesion in the liver according to RECIST. 4) A hepatic arterial catheter and port system placed and the adequate drug distribution confirmed by CT angiography or MR angiography. 5) Age 20 and over. 6) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 7) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions. 8) Expected survival more than 8 weeks. 9) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Extensive tumor involvement to hepatic hilum with or without preceding or scheduled radiation therapy. 2) Infectious disease except viral hepatitis with fever over 38 degree Celcius or antibiotics required. 3) Concurrent uncontrolled medical condition. 4) Active other malignancy. 5) Allergic reaction to iodine contrast material. 6) Severe mental disorder. 7) Pregnant or nursing. 8) Hepatic arterial catheter and port system placed by laparotomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reaction | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, response rate for intrahepatic lesions, overall response rate. | — |
Countries
Japan
Contacts
Public ContactYasuaki Arai
JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital
Outcome results
None listed