Unique ID issued by UMIN | UMIN000010001 |
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Receipt number | R000011709 |
Scientific Title | Retrospective observational study to investigate the predictive factors about the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma. |
Date of disclosure of the study information | 2013/02/08 |
Last modified on | 2015/03/02 20:06:48 |
Retrospective observational study to investigate the predictive factors about the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma.
Retrospective observational study to investigate the predictive factors about the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma.
Retrospective observational study to investigate the predictive factors about the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma.
Retrospective observational study to investigate the predictive factors about the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma.
Japan |
Hepatocellular carcinoma
Hepato-biliary-pancreatic medicine |
Malignancy
YES
Investigate the predictive factors about the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma.
Efficacy
The clinicopathological factors related to time to progression of unresectable advanced hepatocellular carcinoma.patients treated with sorafenib.
The clinicopathological factors related to overall survival of unresectable advanced hepatocellular carcinoma patients treated with sorafenib.
The clinicopathological factors to predict serious adverse effects caused by sorafenib.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Patients with unresectable advanced hepatocellular carcinoma treated with sorafenib.
none
400
1st name | |
Middle name | |
Last name | Namiki Izumi |
Musashino Red Cross Hospital
Division of Gastroenterology and Hepatology
1-26-1, Kyonancho, Musashino, Tokyo
1st name | |
Middle name | |
Last name | Yukio Osaki |
Osaka Red Cross Hospital
Depertment of Gastroenterology and Hepatology
5-30, Fudegasaki-cho, Tennoji-ku, Osaka
Japanese Red Cross Liver Study Group
Ministry ofHealth, Labour and Welfare
Department of Genome Biology
NO
武蔵野赤十字病院, 大阪赤十字病院, その他全国赤十字病院
2013 | Year | 02 | Month | 08 | Day |
Partially published
This study included 259 males and 57 females with a median age of 70 years, of which 191 (60.4%) were classified as Barcelona Clinic Liver Cancer stage C, and 271 (85.8%) had Child-Pugh class A liver function. The median overall survival time was 307 days and progression-free survival time was 109 days. According to the modified Response Evaluation Criteria In Solid Tumours, four patients achieved a complete response, 51 achieved a
partial response, 136 had stable disease and 125 had progressive disease. Multivariate analysis identified female gender (P = 0.003) and decreased serum
AFP level after 1 month (P = 0.042) as independent predictors of a complete
or partial response.
Main results already published
2012 | Year | 05 | Month | 15 | Day |
2012 | Year | 06 | Month | 22 | Day |
2013 | Year | 10 | Month | 31 | Day |
2013 | Year | 12 | Month | 31 | Day |
2014 | Year | 01 | Month | 15 | Day |
2014 | Year | 03 | Month | 31 | Day |
To investigate the predictive factors on the efficacy of sorafenib therapy for unresectable advanced hepatocellular carcinoma.
To perform genomic analyses on patients` tumor tissue obtained by liver biopsy before sorafenib administration, and to investigate biomarkers related to clinical course including OS, PFS and adverse effects.
2013 | Year | 02 | Month | 08 | Day |
2015 | Year | 03 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011709
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