pilot study of intraarterial 5-fluorouracil/interferon combination therapy for advanced hepatocellular carcinoma patients who do not response to intraarterial 5-fluorouracil/cisplatin combination therapy.

UMIN ID: UMIN000002928

Registered date:22/12/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: advanced hepatocellular caricinoma
• Date of first enrollment: 2009/08/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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. Recombinant interferon alfa-2b 3*106 U (3MU) was administered intramuscularly on days 1, 3 and 5 of each week. 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: response rate
• Secondary Outcome: 1) overall survival 2) time to progression 3) safety

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 IFN. 7) With severe bone marrow supression. 8) With pulmonary fibrosis. 9) with shosaikoto 10) with autoimmune hepatitis

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