NIPH Clinical Trials Search

UMIN ID: C000000049

Registered date:07/08/2005

A phase I/II study of transarterial chemoembolization with cisplatin for hepatocellular carcinoma (JIVROSG-0401)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedUnresectable hypervascular hepatocellular carcinoma
Date of first enrollment2005/10/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Patients undergo transarterial chemoembolization comprising intra-arterial infusion of cisplatin over 20-40 minutes followed by embolization with gelatin sponge particle until elimination of tumor stain is observed on proper hepatic arteriogram.


Primary OutcomeAdverse events
Secondary OutcomeResponse rate of liver tumor and overall response rate

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1) Prior chemotherapy with cisplatin for HCC. 2) Suspicious of extra-hepatic arterial blood supply to lesions on contrast-enhanced CT. 3) Extra-hepatic arterial blood supply to lesions on prior angiography. 4) Surgical reconstruction or endoscopic treatment involving biliary system. 5) Lymphnode metastasis or distant metastasis. 6) Other uncontrolled severe illness. 7) Active infectious disease except viral hepatitis. 8) Active other malignancies. 9) Allergic reaction to iodine contrast material, platinum containing agent, or gelatin containing agent. 10) Pregnant or nursing.

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 Keigo Osuga
Address 2-2, Yamadaoka, Suita, Osaka 565-0871, Japan Japan
Telephone 06-6879-3434
Affiliation Osaka University Graduate School of Medicine Department of Radiology