UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030850 |
|---|---|
| Receipt number | R000035224 |
| Scientific Title | An observational study to discover novel biomarkers for nivolumab in patients with advanced gastric cancer (DELIVER trial): JACCRO GC-08 |
| Date of disclosure of the study information | 2018/01/17 |
| Last modified on | 2020/07/21 10:04:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
An observational study to discover novel biomarkers for nivolumab in patients with advanced gastric cancer (DELIVER trial): JACCRO GC-08
Acronym
An observational/translational study for nivolumab in gastric cancer (DELIVER trial): JACCRO GC-08
Scientific Title
An observational study to discover novel biomarkers for nivolumab in patients with advanced gastric cancer (DELIVER trial): JACCRO GC-08
Scientific Title:Acronym
An observational/translational study for nivolumab in gastric cancer (DELIVER trial): JACCRO GC-08
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to evaluate efficacy and safety of nivolumab treatment for advanced gastric cancer in clinical practice. The translational study also is performed to identify the predictive factors for efficacy or toxicity of nivolumab by analyzing gut microbiome, genetic polymorphism, gene expression, and metabolome in plasma before and after treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall Survival
Key secondary outcomes
Response Rate, Disease Control Rate, Depth of Response, Tumor Shrinkage Rate, Tumor Progression Rate, Progression-Free Survival, Safety, Biomarker Analysis
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) Patients with histologically confirmed diagnosis of adenocarcinoma of the GEJ/gastric cancer.
(2) Patients treated with nivolumab alone treatment (in any lines).
(3) ECOG performance status 0-2.
(4) 20 years of age or more.
(5) Patients with potential to collect feces and blood before and after nivolumab treatment.
(6) Written informed consent.
Key exclusion criteria
(1) Patients previously treated with nivolumab
(2) HBs antigen-positive or HCV antibody-positive
(3) Patients who are regarded as inadequate for study enrollment by investigators.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Sunakawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL
044-977-8111
y.sunakawa@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Fujii |
Organization
Japan Clinical Cancer Research Organization (JACCRO)
Division name
Office
Zip code
104-0061
Address
1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL
03-5579-9882
Homepage URL
gc08.dc@jaccro.or.jp
Sponsor or person
Institute
Japan Clinical Cancer Research Organization (JACCRO)
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
DNA Chip Research Inc.
Name of secondary funder(s)
Bristol-Myers Squibb Co. Ltd.
IRB Contact (For public release)
Organization
Japan Clinical Cancer Research Organization Institutional Review Board
Address
7F Ginza Wing Bil.,1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
Tel
03-5579-9882
jaccro@jaccro.or.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
聖マリアンナ医科大学（神奈川県）他
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
501
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
| 2018 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
prospective observational study.
We research about patient backgrounds, treatment, safety and efficacy.
Management information
Registered date
| 2018 | Year | 01 | Month | 17 | Day |
Last modified on
| 2020 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035224
