Unique ID issued by UMIN | UMIN000043208 |
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Receipt number | R000049315 |
Scientific Title | observational/translational study for nivolumab treatment in advanced esophageal cancer |
Date of disclosure of the study information | 2021/02/01 |
Last modified on | 2021/02/01 15:53:33 |
observational/translational study for nivolumab treatment in advanced esophageal cancer
observational/translational study for nivolumab treatment in advanced esophageal cancer
observational/translational study for nivolumab treatment in advanced esophageal cancer
observational/translational study for nivolumab treatment in advanced esophageal cancer
Japan |
esophageal cancer
Gastroenterology |
Malignancy
NO
The purpose of this study is to evaluate efficacy and safety of nivolumab treatment for advanced esophageal cancer in clinical practice. The translational study also is performed to identify the predictive factors for efficacy or toxicity of nivolumab by analyzing oral and gut microbiome.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
overall survival
progression-free survival, response rate, safety, dose intensity, biomarker analysis
Observational
20 | years-old | <= |
Not applicable |
Male and Female
(1) Patients with histologically confirmed diagnosis of squamaous cell carcinoma of the esophageal cancer.
(2) Patients treated with nivolumab.
(3) 20 years of age or more.
(4) ECOG performance status 0-2.
(5) Patients with potential to collect saliva and feces.
(6) expected more than 3 months
(6) Written informed consent.
(1) Patients previously received major gastrointestinal surgery
(2) Patients previously treated with nivolumab.
(3) Patients who are regarded as inadequate for study enrollment by investigators.
25
1st name | Yoshito |
Middle name | |
Last name | Komatsu |
Hokkaido University Hospital
Divison of Cancer Center
060-8648
Kita14, Nishi5, Kita-ku, Sapporo, Hokkaido
0117161161
ykomatsu@ac.cyberhome.ne.jp
1st name | Shintaro |
Middle name | |
Last name | Nakano |
Hokkaido university hospital
Divison of Cancer Center
060-8648
Kita14, Nishi5, Kita-ku, Sapporo, Hokkaido
0117161161
shintaro-n@frontier.hokudai.ac.jp
Hokkaido Gastrointestinal Cancer Study Group
ONO PHARMACEUTICAL CO., LTD.
Profit organization
Hokkaido University Hospital Division of Clinical Research Administration
Kita14, Nishi5, Kita-ku, Sapporo, Hokkaido
011-706-7636
crjimu@huhp.hokudai.ac.jp
NO
北海道大学病院他
2021 | Year | 02 | Month | 01 | Day |
Unpublished
Open public recruiting
2020 | Year | 11 | Month | 06 | Day |
2020 | Year | 11 | Month | 19 | Day |
2020 | Year | 12 | Month | 01 | Day |
2023 | Year | 10 | Month | 31 | Day |
2023 | Year | 10 | Month | 31 | Day |
2023 | Year | 12 | Month | 31 | Day |
2024 | Year | 10 | Month | 31 | Day |
prospective observational study.
We research about patient backgrounds, treatment efficacy and safety.
2021 | Year | 02 | Month | 01 | Day |
2021 | Year | 02 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049315
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