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 |
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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 |
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Secondary Outcome | adverse events, overall survival, progression free survival |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
Secondary ID(s) |
Contact
public contact | |
Name | Kohei Nakachi |
Address | Sapporo Japan |
Telephone | 0155-22-6600 |
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 |
jfuruse@ks.kyorin-u.ac.jp | |
Affiliation | Kyorin University medical oncology |