Unique ID issued by UMIN | UMIN000040462 |
---|---|
Receipt number | R000046184 |
Scientific Title | A study of biomarker predicting the effort and the adverse event of Nivolumab for unresectable advanced or recurrent esophageal cancer |
Date of disclosure of the study information | 2020/05/21 |
Last modified on | 2020/05/20 17:06:28 |
A study of biomarker predicting the effort and the adverse event of Nivolumab for unresectable advanced or recurrent esophageal cancer
Biomarker research of Nivolumab for esophageal cancer
A study of biomarker predicting the effort and the adverse event of Nivolumab for unresectable advanced or recurrent esophageal cancer
Biomarker research of Nivolumab for esophageal cancer
Japan |
Unresectable advanced or recurrent esophageal cancer
Gastrointestinal surgery |
Malignancy
YES
To search predictive biomarker of Nivolumab treatment for unresectable advanced and recurrent esophageal cancer by immunohistochemical examination and flowcytometry
Safety,Efficacy
Association with effect of treatment and the expression of each factor in the Nivolumab treatment
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1)The patients who are Nivolumab single administration plan for unresectable advanced or recurrent esophageal cancer that we aggravated after the cancer chemotherapy.
2)Squamous cell carcinoma is diagnosed by an examination of histopathology.
3)By RECIST(Response Evaluation Criteria in Solid Tumors version 1.1) criteria,
We have at least one measurable lesion or immeasurable lesion.
4)Sex: No object
5)Age (at the agreement acquisition): 20 years or older
6)Performance Status Score (ECOG) is the patient of 0-1
7)The patients whom the radical excision is not indicated for
8)The patients that survival three months or more is anticipated
9)The patients that an agreement is obtained from the person about study entry
1)The patients whom remarkable malnutrition is found in.The patients receiving a central venous feeding method or the patients needing persistent transfusion by the hospitalization do it with exclusion.
2)The patients whom clear invasion is found in with tumor to the organ (including an aorta and the trachea) near the esophagus lesion. Also, the patients giving a stent therapy in esophagus or the trachea do it with exclusion.
3)We have multiple primary cancer of the activity at the beginning of Nivolumab administration.(Synchronism multiple primary cancer/frequent occurrence cancer and disease-free interval are metachronous multiple primary cancer/frequent occurrence cancers within five years.However, we do not include the lesion of carcinoma in situ and the intramucosal carcinoma equivalency judged to be able to be cured by local treatment in multiple primary cancer/frequent occurrence cancer of the activity.)
4)The patients with a merger of the extensive hypersensitivity reaction for other antibody preparations or the history.
5)The patients who cannot control the pain associated with tumor.
6)The patients who had uncontrollable diabetes.
7)The patients with vascular infection or the history.
8)The patients with the systemic infection to require treatment.
9)It is during the nursing or the patients who may be pregnant during pregnancy.
10)It is the patients with the previous history of treatment with ONO-4538(MDX-1106 or BMS-9365558), antiPD-1/PD-L1/PD-L2/CD137/CTLA-4 antibody or antibody therapy for the purpose other T-cell control or pharmacotherapy in the past.
11)The patients who are judged to be in condition to write ability for agreement by mergers, and the like with dementia.
12)In addition, the patients whom a chief physician, attending staff judged to be inadequate as this study subject
100
1st name | Yuichirou |
Middle name | |
Last name | Doki |
Graduated School of Medicine,Osaka University
Department of Gastroenterological Surgery
565-0871
2-2-E2,Yamadaoka,Suita City,Osaka
06-6879-3251
ydoki@gesurg.med.osaka-u.ac.jp
1st name | Tomoki |
Middle name | |
Last name | Makino |
Graduated School of Medicine,Osaka University
Department of Gastroenterological Surgery
565-0871
2-2-E2,Yamadaoka,Suita City,Osaka
06-6879-3251
tmakino@gesurg.med.osaka-u.ac.jp
Osaka University
No
Other
Osaka Univercity
2-2-E21-25C,Yamadaoka,Suita City,Osaka
06-6879-3257
mmikamori@gesurg.med.osaka-u.ac.jp
NO
2020 | Year | 05 | Month | 21 | Day |
Unpublished
Open public recruiting
2020 | Year | 04 | Month | 28 | Day |
2020 | Year | 04 | Month | 28 | Day |
2020 | Year | 04 | Month | 29 | Day |
2026 | Year | 03 | Month | 31 | Day |
Observation study
2020 | Year | 05 | Month | 20 | Day |
2020 | Year | 05 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046184
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |