pilot study of systemic combination therapy with TS-1 and IFN for hepatocellular carcinoma patients with extrahepatic metastases who do not response to systemic combination therapy with TS-1 and cisplatin.

UMIN ID: UMIN000002929

Registered date:22/12/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: hepatocellular carcinoma with extrahepatic metastases
• Date of first enrollment: 2009/09/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Two weeks represented one cycle of treatment. In each cycle, S-1 was administered orally at a dose of 80-120 mg daily (depending on body surface area: <1.25 m2, 80 mg; 1.25-1.5 m2, 100 mg; ≥1.5 m2, 120 mg), and CDDP was administered intravenously at a dose of 60 mg/m2 on day 8. Each treatment cycle was followed by a two-to-four-week rest period of no treatment. 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, TS-1 or IFN. 7) With severe bone marrow supression. 8) With pulmonary fibrosis. 9) With another fluoropyrimidine 10)With flucytosine 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