hepatocellular carcinoma with bone metastasis
Conditions
Interventions
denosumab
Sponsors
Department of Gastroenterology and Metabolism,Hiroshima University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosis of HCC was confirmed histopathologically. 2) With bone metastasis. 3) With progression of bone metastasis despite of using Zoledronic acid. 4) age > 20 5) PS 0-2 6) a)WBC > 3000/mm3 b)Hb > 9.0 g/dl c)Plt > 75000/mm3 d)Creatine < 3.0mg/dl e)serum Ca >8.5mg/dL,<11.5mg/dL f)Total Bilirubin < 1.8 mg/dl g)AST <90IU/L h)ALT <100IU/L 7) Written Informed Consent must be obtained.
Exclusion criteria
Exclusion criteria: 1) CCr < 30 2) A pregnant woman, or a woman suspected of pregnancy. 10) Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment. 3) With odontogenic infection. 4) Patients participating in other clinical trial. 5) Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Marker of bone resorption | — |
Secondary
| Measure | Time frame |
|---|---|
| Brief Pain Inventory score, Decreasing rate of marker of bone resorption compared to pre-treatment, Adverse events(renal dysfunction, serum Ca value, osteonecrosis of the jaw) | — |
Countries
Japan
Contacts
Public ContactHiroshi Aikata
Hiroshima University Hospital Department of Gastroenterology and Metabolism
Outcome results
None listed