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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040462
Receipt No. 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

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Basic information
Public title A study of biomarker predicting the effort and the adverse event of Nivolumab for unresectable advanced or recurrent esophageal cancer
Acronym Biomarker research of Nivolumab for esophageal cancer
Scientific Title A study of biomarker predicting the effort and the adverse event of Nivolumab for unresectable advanced or recurrent esophageal cancer
Scientific Title:Acronym Biomarker research of Nivolumab for esophageal cancer
Region
Japan

Condition
Condition Unresectable advanced or recurrent esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To search predictive biomarker of Nivolumab treatment for unresectable advanced and recurrent esophageal cancer by immunohistochemical examination and flowcytometry
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Association with effect of treatment and the expression of each factor in the Nivolumab treatment
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yuichirou
Middle name
Last name Doki
Organization Graduated School of Medicine,Osaka University
Division name Department of Gastroenterological Surgery
Zip code 565-0871
Address 2-2-E2,Yamadaoka,Suita City,Osaka
TEL 06-6879-3251
Email ydoki@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Tomoki
Middle name
Last name Makino
Organization Graduated School of Medicine,Osaka University
Division name Department of Gastroenterological Surgery
Zip code 565-0871
Address 2-2-E2,Yamadaoka,Suita City,Osaka
TEL 06-6879-3251
Homepage URL
Email tmakino@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization No
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka Univercity
Address 2-2-E21-25C,Yamadaoka,Suita City,Osaka
Tel 06-6879-3257
Email mmikamori@gesurg.med.osaka-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2020 Year 04 Month 28 Day
Date of IRB
2020 Year 04 Month 28 Day
Anticipated trial start date
2020 Year 04 Month 29 Day
Last follow-up date
2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observation study

Management information
Registered date
2020 Year 05 Month 20 Day
Last modified on
2020 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.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


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