UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029622 |
|---|---|
| Receipt number | 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 | 2023/04/24 15:04:14 |
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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 | Yasuyuki |
| Middle name | |
| Last name | Seto |
Organization
The University of Tokyo
Division name
Department of Gastrointestinal Surgery
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
seto-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hiroharu |
| Middle name | |
| Last name | Yamashita |
Organization
The University of Tokyo
Division name
Department of Gastrointestinal Surgery
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
hyamashi-tky@umin.net
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo,Intervention Research Ethics Committee
Address
7-3-1,Hongo,Bunkyo-ku,Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 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
19
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
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
| 2023 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033110
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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