pilot study of hepatic resection followed by intraarterial 5-fluorouracil/cisplatin combination therapy for advanced hepatocellular carcinoma with vascular invasion

UMIN ID: UMIN000002930

Registered date:22/12/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: hepatocellular carcinoma with vascular invasion
• Date of first enrollment: 2009/09/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 1) hepatic resection 2) low dose FP One course of chemotherapy represented 2 weeks. 5FU (300 mg/m2/24h) was administered using a mechanical infusion pump on days 1-5 of the first and second weeks. CDDP (6 mg/m2/0.5h) was administered using a mechanical infusion pump on days 1-5 of the first and second weeks. A 2- to 4-week rest period of no treatment was allowed after each treatment course. Treatment was repeatec unless HCC reveales progressive disease (acording to RECIST).

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: 1) time to progression 2) safety 3) response rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) With other malignant disease. 2) A pregnant woman, or a woman suspected of pregnancy. 3) With severe infectious disease. 4) With history of severe allergy. 5) With severe renal function disease. 6) With severe allergy for 5FU or CDDP. 7) With severe bone marrow supression.

Related Information

• Primary Sponsor: Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Biomedical Research, Graduate School of Biomedical, Hiroshima University
• Source(s) of Monetary Support: Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Biomedical Research, Graduate School of Biomedical, Hiroshima University