Unique ID issued by UMIN | UMIN000009675 |
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Receipt number | R000010707 |
Scientific Title | Pilot study of index and safety of switching to Denosumab from Zoledronic acid for hepatocellular carcinoma with bone metastasis. |
Date of disclosure of the study information | 2012/12/31 |
Last modified on | 2019/04/15 20:37:07 |
Pilot study of index and safety of switching to Denosumab from Zoledronic acid for hepatocellular carcinoma with bone metastasis.
Pilot study of Denosumab from Zoledronic acid for hepatocellular carcinoma with bone metastasis.
Pilot study of index and safety of switching to Denosumab from Zoledronic acid for hepatocellular carcinoma with bone metastasis.
Pilot study of Denosumab from Zoledronic acid for hepatocellular carcinoma with bone metastasis.
Japan |
hepatocellular carcinoma with bone metastasis
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To elucidate the efficacy and safety of switching to denosumab from Zoledronic acid for hepatocellular carcinoma with bone metastasis.
Safety,Efficacy
Marker of bone resorption
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)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
denosumab
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
35
1st name | |
Middle name | |
Last name | Kazuaki Chayama |
Hiroshima University Hospital
Department of Gastroenterology and Metabolism
1-2-3 Kasumi, Minami-ku, Hiroshima
1st name | |
Middle name | |
Last name | Hiroshi Aikata |
Hiroshima University Hospital
Department of Gastroenterology and Metabolism
1-2-3 Kasumi, Minami-ku, Hiroshima
082-257-5191
Department of Gastroenterology and Metabolism,Hiroshima University Hospital
Department of Gastroenterology and Metabolism,Hiroshima University Hospital
Self funding
NO
2012 | Year | 12 | Month | 31 | Day |
Unpublished
Completed
2012 | Year | 11 | Month | 15 | Day |
2012 | Year | 12 | Month | 05 | Day |
2012 | Year | 12 | Month | 10 | Day |
2019 | Year | 03 | Month | 31 | Day |
2012 | Year | 12 | Month | 31 | Day |
2019 | Year | 04 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010707
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