Hepatocellular carcinoma
Conditions
Interventions
None listed
Sponsors
Yokohama City University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)At least 20 years old when consent is given 2)Histologically or clinically (imaging and tumor markers) diagnosed hepatocellular carcinoma found to be ineligible for resection or local treatment 3)Lesions measurable with contrast-enhanced CT or contrast-enhanced MRI 4)Child-Pugh class A or B 5)ECOG performance status (PS) of 0 or 1 6) Adequate functional reserve of major organs 7)Capable of complying with requirements about visit days, medication, and laboratory tests 8)The patient has been fully informed and has an adequate understanding about the study and has given voluntary written consent before participation
Exclusion criteria
Exclusion criteria: 1)Clinically significant ascites (refractory ascites requiring drainage) 2)Esophageal varices with the potential to bleed 4)Brain tumor 5)On dialysis 6)Gastrointestinal hemorrhage during past month 7)Active multiple cancer 8)Any of the following concurrent diseases: Grade 3 or greater arrhythmia or poorly controlled hypertension according to the JCOG/JSCO Japanese translation of the NCI Common Terminology Criteria for Adverse Events v 4.0 (CTCAE v 4.0) 9)Orally taking an herbal medicine approved for the treatment of cancer (e.g., shosaikoto) 10)Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related disease 11) Pregnant or nursing 12) Otherwise found ineligible as a subject by the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS OR/DCR Safety | — |
Countries
Japan
Contacts
Public ContactMakoto Chuma
Yokohama City University Medical Center Gastroenterological Center
Outcome results
None listed