Hepatocellular carcinoma
Conditions
Interventions
Blood samples will be collected on routine blood tests before and after the start of sorafenib treatment and at the time of suspension, resumption, and discontinuation of sorafenib treatment. A little
Sponsors
Okayama University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients for whom sorafenib treatment is selected in clinical practice 2) Patients with histologically, cytologically, or radiologically (using contrast-enhanced CT or MRI) confirmed typical HCC 3) Patients with intrahepatic or extrahepatic lesion that is judged to be unresectable on diagnostic imaging 4) Patients 20 to <90 years of age at the time of informed consent 5) Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 6) Patients with adequate function of major organs on laboratory tests 1 month before enrollment (1) Neutrophils: >1,500/mm3 (2) Hemoglobin: >=8.5 g/dL (3) Platelets: >50,000/mm3 (4) Serum total bilirubin: <2.0 mg/dL (5) Serum AST/ALT: not more than 5 times the institution's upper limit of normal (ULN) (6) Serum creatinine: not more than 1.5 times the institution's ULN 7) Patients who have provided written informed consent for participation in this study
Exclusion criteria
Exclusion criteria: 1) Patients with histologically confirmed mixed-type HCC or sarcomatous change 2) Patients with a history of molecular-targeted therapy 3) Patients with active double cancer (Patients who have early-stage cancer that does not appear to affect their prognosis and can be controlled by treatment may be enrolled in this study.) 4) Patients with any serious coexisting condition (e.g., ileus, interstitial pneumonia, pulmonary fibrosis, difficult-to-control diabetes mellitus, hypertension, cardiac failure, renal failure, hepatic failure, active peptic ulcer, varicose veins in danger of rupture, severe mental disorder or depression) 5) Patients with ascites and/or pleural effusion unresponsive to treatment 6) Patients judged by the principal investigator or subinvestigator to be unsuitable for participation for any other reason (to ensure the safe conduct of this study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from sorafenib treatment initiation to 1st progression (1st TTP) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) Incidence of adverse events Tumor marker assessment Time from first disease progression to second progression (2nd TTP) | — |
Countries
Japan
Contacts
Public ContactKazuhiro Nouso
Okayama University Hospital Department of Gastroenterology
Outcome results
None listed