advanced hepatocellular carcinoma
Conditions
Interventions
None listed
Sponsors
Sapporo Medical University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or clinically (imaging and tumor markers) diagnosed hepatocellular carcinoma 2)Not eligible for local treatment (e.g., surgery, RFA, TAE, and ethanol injection) 3)Lesions evaluable with contrast-enhanced computed tomography (CT) or contrast- enhanced magnetic resonance imaging (MRI) 4)No carryover of effects or adverse effects of prior treatmen 5)Child-Pugh Score 5-8 6)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 7)Adequate functional reserve of major organs 8)Patients with systolic blood pressure of 140 mmHg or less and diastolic blood pressure of 90 mmHg or less 9)Over 20 years old 10) Capable of complying with requirements with respect to visit days, medication, and laboratory tests 11)The patient provides written informed consent before the start of the clinical study
Exclusion criteria
Exclusion criteria: 1)Clinically significant ascites (i.e., refractory ascites requiring drainage) 2)History of liver transplantation 3)Esophageal varices with the potential to bleed 4)Concurrent or prior hepatic encephalopathy 5)Brain tumor 6)Currently on dialysis 7)Active double cancer 8)Orally taking an herbal medicine approved for the treatment of cancer (e.g., sho-saiko-to) 9)Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) -related disease 10)Pregnant or nursing 11)Otherwise found by the investigator or subinvestigator to be ineligible as a subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy | — |
Countries
Japan
Contacts
Public ContactNoriyuki Akutsu
Sapporo Medical University School of Medicine Department of Gastroenterology and Hepatology
Outcome results
None listed