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
- Conditions
- Advanced hepatocellular carcinoma with extrahepatic metastasis
- Registration Number
- JPRN-UMIN000000774
- Lead Sponsor
- Graduate School of Medicine, Osaka University Department of Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 120
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival
- Secondary Outcome Measures
Name Time Method Clinical Response (anti-tumor effect) Progression Free Survival Incidence of Adverse Event