NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000809

Registered date:31/08/2007

Phase II study of hepatic arterial infusion of cisplatin for unresectable intrahepatic cholangiocarcinoma

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedintrahepatic cholangiocarcinoma
Date of first enrollment2007/08/01
Target sample size35
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)CDDP is administered at a dose of 65 mg/m2 into the hepatic artery. The treatment is repeated every 4 to 6 weeks until a maximum of 6 courses, the appearance of unacceptable toxicity, or disease progression.

Outcome(s)

Primary Outcomeresponse rate
Secondary Outcomeadverse events, overall survival, progression free survival

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) presence of uncontrollable ascites or pleural effusion 2) cerebral or bone metastasis 3) uncontrollable cardiovascular disease or prior myocardial infarction 4) active infection other than HBV or HCV 5) other malignancy 6) severe psychiatric disorder 7) severe drug allergy 8) pregnant or nursing

Related Information

Contact

public contact
Name Kohei Nakachi
Address Sapporo Japan
Telephone 0155-22-6600
E-mail knakachi-gi@umin.org
Affiliation Sapporo Medical University Gastroenterology
scientific contact
Name Junji Furuse
Address 6-5-1, Kashiwanoha, Kashiwa Japan
Telephone 03-3412-1111
E-mail jfuruse@ks.kyorin-u.ac.jp
Affiliation Kyorin University medical oncology