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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029622
Receipt No. R000033110
Scientific Title Analysis of intratumoral immune response early on Nivolumab treatment in unresectable advanced or recurrent gastric cancer.
Date of disclosure of the study information 2017/10/19
Last modified on 2017/12/05

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Basic information
Public title Analysis of intratumoral immune response early on Nivolumab treatment in unresectable advanced or recurrent gastric cancer.
Acronym Intratumoral immune response early on Nivolumab treatment in gastric cancer.
Scientific Title Analysis of intratumoral immune response early on Nivolumab treatment in unresectable advanced or recurrent gastric cancer.
Scientific Title:Acronym Intratumoral immune response early on Nivolumab treatment in gastric cancer.
Region
Japan

Condition
Condition Unresectable advanced or recurrent gastric cancer
Classification by specialty
Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Analyze intratumoral immune response early on Nivolumab treatment in unresectable advanced or recurrent gastric cancer to reveal predictive biomarkers for Nivolumab.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Durable clinical benefit rate, DCBR (DCR more than 4 months)
Key secondary outcomes Immunological responses
Response rate, RR
Disease control rate, DCR
Progression free survival, PFS
Overall survival, OS
Adverse events, AE
Quality of life, QOL

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.Histologically diagnosed gastric or esophagogastric junction adenocarcinoma.
2.Unresectable advanced or recurrent tumor.
3.Age over 20 years old.
4.ECOG Performance status of 0-2.
5.With lesions being able to be biopsied (measurable lesions not required).
6.With valuable lesion according to RECIST ver 1.1.
7.More than 42 days after failure of standard therapy.
8.More than 14 days after last infusion of chemotherapy.
9.Adequate organ and marrow functions as defined below within 14 days prior to registration:
(i)Absolute neutrophil =>1,000/mm3.
(ii)Hemoglobin =>9.0g/dL.
(iii)Platelet =>50,000/mm3.
(iv)Total bililubin =<2.0xupper limits of normal (ULN) .
(v)AST =<3.0xULN (in the case or liver metastases, physician's choice is allowed) .
(vi)ALT =<3.0xULN (in the case or liver metastases, physician's choice is allowed) .
(vii)Creatinine =<1.5mg/dL or eGFR =>45ml/min/1.73m2.
10.Written Informed Consent.
Key exclusion criteria 1.Synchronous or metachronous (within 5 years) double cancers, except for intoramucosal tumor curatively resected by local therapy
2.Active infection requiring systemic therapy.
3.Active autoimmune diseases or with a history of chronic or repetitive autoimmune diseases.
4.With a history of interstitial pneumonia, pulmonary fibrosis or irradiation pneumonitis.
5.Active diverticulitis or inflammatory bowel disease.
6.Poorly controlled diabetes mellitus or thyroid diseases.
7.Unstable angina within 3 weeks or with a history of acute myocardial infarction within 3months.
8.Severe psychological illness.
9.Pregnant or lactating women or women of childbearing potential.
10.Within 4 weeks after live vaccination or 2 weeks after inactiviated vaccination.
11.Judged to be unfit to participate in this study by investigater.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyuki Seto
Organization The University of Tokyo
Division name Department of Gastrointestinal Surgery
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email seto-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroharu Yamashita
Organization The University of Tokyo
Division name Department of Gastrointestinal Surgery
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email hyamashi-tky@umin.net

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD.Bristol-Myers Squibb
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 10 Month 19 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
2017 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2017 Year 10 Month 19 Day
Last modified on
2017 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033110

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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