Multicenter Phase II Randomized Controlled Trial of S-1 and Interferon-alpha Combined Chemotherapy or S-1 Alone in Advanced Hepatocellular Carcinoma with Extrahepatic Metastasis

UMIN ID: UMIN000000774

Registered date:26/07/2007

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Advanced hepatocellular carcinoma with extrahepatic metastasis
• Date of first enrollment: 2007/06/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

S-1 80mg/m2 per os day1~28 and no administration day29~42 for 1 course Treatment repeats every 42 days for 2-6 courses
S-1 80mg/m2 per os day1~28 IFN-alpha 5 million units sc 3 times a week for 4 weeks and no administration day29~42 Treatment repeats every 42 days for 2-6 courses

Outcome(s)

• Primary Outcome: Overall Survival
• Secondary Outcome: Clinical Response (anti-tumor effect) Progression Free Survival Incidence of Adverse Event

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) Histologically diagnosed combined type of hepatocellular carcinoma and cholangiocellular carcinoma in primary lesion. 2) Radiographic evidence of portal vein tumor thrombus in major branch or first branches (Vp3 or Vp4 in the liver cancer study group of Japan.) 3) Radiographic evidence of vascular invasion in hepatic vein or hepatic artery or bile duct. 4) Known bone metastasis. 5) Known brain metastasis. 6) Hepatic encephalopathy. 7) Active infectious disease. 8) Other severe concomitant disease or medical conditions. 9) Chronic diarrhea or any disorder that will limit adequate absorption of S-1. 10) Other malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, from which the patient has been disease-free for 5 years. 11) Pregnant or lactating women. 12) Concurrent systemic chemotherapy. 13) Any contraindication for S-1 medication. 14) Any contraindication for interferon-alpha administration. 15) Inappropriate patients for entry on this trial in the judgement of the investigator.

Related Information

• Primary Sponsor: Graduate School of Medicine, Osaka University Department of Surgery
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare