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

UMIN ID: UMIN000000809

Registered date:31/08/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: intrahepatic cholangiocarcinoma
• Date of first enrollment: 2007/08/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• 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 Outcome: response rate
• Secondary Outcome: adverse events, overall survival, progression free survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) 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

• Primary Sponsor: Division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare