Hepatocellular carcinoma (HCC) with chronic liver diseases by Hepatitis C virus (HCV) infection (after radical HCC treatment)
Conditions
Interventions
Oral admistration of Rifampicin 300 mg/day everyday for 84 weeks
Best supprtive care
Sponsors
Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University
Tsuchiura Kyodo General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients aged >= 20 years to < 80 years at informed consent and notified disease (2) Outpatients (3) Patients at 30 to 60 days after radical HCC treatment (4) Patients who meet following criteria before radical HCC treatment a. Patients with no preceding treatment, and patients with single or double preceding HCC treatment b. Patients who have been diagnosed with HCC by histologically or typical diagnostic images (using dynamic CT and/or Gd-EOB-DTPA-enhanced MRI) c. Patients without preoperative evidence of macroscopic vascular invasion (Vp, Vv, B) (5) Patients with an ECOG performance status (PS) of 0 or 1 (6) Written Informed consent must be obtained
Exclusion criteria
Exclusion criteria: (1) Not consent to observe the regulation about concomitant drug and concomitant therapy (2) Patients with complications that influence on serum alanine aminotransferase or aspartate aminotransferase, including polymyositis, acute myocardial infarction, and gallstone. (3) Patients under dialysis therapy (4) Patients with liver diseases due to chronic viral hepatitis (except for Hepatitis C virus), liver failure, alcohol abuse, drug-induced liver damage, autoimuune hepatitis, and primary biliary cirrhosis. (5) Patients with obstruction of bile duct. Patients with severe liver diseases, who meet one of following criteria # Child-Pugh grade C # Hepatic encephalopathy # Total bilirubin >= 3mg/dL # Decompensated liver cirrhosis # AST >= 500IU/L # ALT >= 500IU/L (6) Patient with any other cancer (7) Patients of porphyria (8) Past history of hypersensitivity for Rifampicin (9) Preceding administration of other investigational agent within 24 weeks before enrollment of this study (10) Patients with pregnancy, lactation or possibility of pregnancy. Not consent to use contraceptive method during the study treatment. (11) Patients with active infectious diseases due to methicillin-resistant Staphylococcus aureus, atypical Mycobacteria, and Mycobacterium tuberculosis (12) Patients under chemotherapy of anti-cancer drug (Local or Systemic) or radiotherapy (13) Preceding enrollment of this study, and preceding administration of Rifampicin (14) Any patients judged by the investigators to be unfit to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Serum alanine aminotransferase, (2) Serum aspartate aminotransferase, (3) Serum lactate dehydrogenase, (4) Serum alpha-fetoprotein, (5) Serum lens culinaris agglutinin-reactive fraction of AFP (AFP-L3), (6) Serum protein induced by vitamin K absence or antagonist-II (PIVKA-II), (7) Serum level of Vascular endothelial growth factor, (8) One-year recurrence | — |
Countries
Japan
Contacts
Public ContactSei Kakinuma
University Hospital of Medicine, Tokyo Medical and Dental University Department of Gastroenterology and Hepatology
Outcome results
None listed