advanced hepatocellular carcinoma
Conditions
Interventions
Sponsors
Sapporo Medical University Hospital
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 measurable with contrast-enhanced computed tomography (CT) or contrast- enhanced magnetic resonance imaging (MRI) 4)No carryover of effects or adverse effects of prior treatment (A washout period of at least 2 weeks will be established before the start of the clinical study for patients who have undergone hepatic resection, percutaneous local treatment, TAE, hepatic arterial infusion, and radiation therapy.) 5)Child-Pugh class A 6)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 7)Adequate functional reserve of major organs 8)Over 20 years old 9)Capable of complying with requirements with respect to visit days, medication, and laboratory tests 10)The patient provides written informed consent before the start of the clinical study
Exclusion criteria
Exclusion criteria: 1)History of use of sorafenib or another molecular-targeted drug 2)History of systemic chemotherapy 3)Clinically significant ascites (i.e., refractory ascites requiring drainage) 4)History of liver transplantation 5)Esophageal varices with the potential to bleed 6)Any of the following diseases within 12 months before enrollment in the clinical study: myocardial infarction, unstable angina, cardiac failure, and cerebrovascular disorder 7)Concurrent or prior hepatic encephalopathy 8)Brain tumor 9)Currently on dialysis 10)Gastrointestinal hemorrhage during the previous month 11)Active double cancer 12)Currently treated with a CYP3A4 inducer (e.g., rifampicin) 13)Serious coexisting disease (NCI CTCAE grade 2 or higher arrhythmia and poorly controlled hypertension) 14)History of hypersensitivity to any component of the study drug 15)Orally taking an herbal medicine approved for the treatment of cancer (e.g., sho-saiko-to) 16)Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) -related disease 17)Pregnant or nursing 18)Otherwise found by the investigator or subinvestigator to be ineligible as a subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety after documentation of the first PD | — |
Countries
Japan
Contacts
Public ContactNoriyuki Akutsu
Sapporo Medical University Hospital First Department of Internal Medicine
Outcome results
None listed