A phase II trial of hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma with portal vein tumor thrombosis

UMIN ID: UMIN000000488

Registered date:12/09/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Advanced hepatocellular carcinoma with portal vein tumor thrombosis
• Date of first enrollment: 2005/01/01
• Target sample size: 25
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): A dose of 65 mg/m2 of cisplatin is administered for 20 to 40 minutes from hepatic artery. Treatment is repeated every 4 to 6 weeks for a maximum of six courses, if there is no evidence of tumor progression or unacceptable toxicity.

Outcome(s)

• Primary Outcome: response rate
• Secondary Outcome: adverse events, survival, and progression free survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Prior chemotherapy with cisplatin for hepatocellular carcinoma 2) Prior radiotherapy, transcatheter arterial chemoembolization, and hepatic arterial chemotherapy for portal vein tumor thrombosis of hepatocellular carcinoma 3) Refractory pleural effusion or ascites 4) Distant metastases 5) Allergic reaction to iodine contrast material 6) Severe renal disease 7) Severe heart disease 8) Active infection excluding hepatitis B or C viral infection 9) Active concomitant malignancy 10) Severe mental disorder 11) Severe allergic reaction to drug 12) Pregnant and lactating females; females of childbearing age unless using effective contraception

Related Information

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