NIPH Clinical Trials Search

UMIN ID: C000000048

Registered date:07/08/2005

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedUnresectable cholangiocarcinoma
Date of first enrollment2004/05/01
Target sample size25
Countries of recruitmentJapan
Study typeInterventional
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.


Primary OutcomeAdverse reaction
Secondary OutcomeResponse rate, response rate for intrahepatic lesions, overall response rate.

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) 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


public contact
Name Yasuaki Arai
Address 5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan Japan
Telephone 03-3542-2511
Affiliation JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital
scientific contact
Name Yoshitaka Inaba
Address 1-1, Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan Japan
Telephone 052-762-6111
Affiliation Aichi Cancer Center Department of Diagnostic Radiology