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

UMIN ID: C000000049

Registered date:07/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Unresectable hypervascular hepatocellular carcinoma
• Date of first enrollment: 2005/10/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: Adverse events
• Secondary Outcome: Response rate of liver tumor and overall response rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) 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

• Primary Sponsor: Japan Interventional Radiology in Oncology Study Group (JIVROSG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare