Phase I/II study of hepatic arterial infusion chemotherapy of gemcitabine for unresectable cholangiocarcinoma (JIVROSG-0301)

UMIN ID: C000000048

Registered date:07/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Unresectable cholangiocarcinoma
• Date of first enrollment: 2004/05/01
• Target sample size: 25
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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 progression or unacceptable toxicity.

Outcome(s)

• Primary Outcome: Adverse reaction
• Secondary Outcome: Response rate, response rate for intrahepatic lesions, overall response rate.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Japan Interventional Radiology in Oncology Study Group (JIVROSG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare