UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055039 |
|---|---|
| Receipt number | R000062878 |
| Scientific Title | Investigation of whether the Glasgow Prognostic Score is a predictor of response to nivolumab in combination with low-dose ipilimumab as first-line therapy in patients with advanced gastric or esophagogastric junction cancer with MSI-H(WJOG18624G) |
| Date of disclosure of the study information | 2024/07/22 |
| Last modified on | 2025/11/17 09:23:30 |
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Basic information
Public title
Investigation of whether the Glasgow Prognostic Score is a predictor of response to nivolumab in combination with low-dose ipilimumab as first-line therapy in patients with advanced gastric or esophagogastric junction cancer with MSI-H(WJOG18624G)
Acronym
CPS evaluation in NO LIMIT study
Scientific Title
Investigation of whether the Glasgow Prognostic Score is a predictor of response to nivolumab in combination with low-dose ipilimumab as first-line therapy in patients with advanced gastric or esophagogastric junction cancer with MSI-H(WJOG18624G)
Scientific Title:Acronym
GPS evaluation in NO LIMIT study
Region
| Japan |
Condition
Condition
Advanced gastric or oesophagogastric junction cancer with MSI-H
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect C-reactive protein (CRP) values at screening and calculate the Glasgow Prognostic Score in patients with advanced gastric or oesophagogastric junction cancer with MSI-H who participated in the NO LIMIT study.
Basic objectives2
Others
Basic objectives -Others
To collect C-reactive protein (CRP) values at screening and calculate the Glasgow Prognostic Score in patients with advanced gastric or oesophagogastric junction cancer with MSI-H who participated in the NO LIMIT study.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To collect CRP values at screening in patients with advanced gastric or oesophagogastric junction cancer with MSI-H who participated in the WJOG13320G/CA209-7W7 (hereafter NO LIMIT) study and calculate the Glasgow Prognostic Score
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Enrolled in the NO LIMIT trial and treated with NIVO+IPI
Key exclusion criteria
None
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | Hisato |
| Middle name | |
| Last name | Kawakami |
Organization
Kindai University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-Sayama, Osaka
TEL
072-366-0221
kawakami_h@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ishizuka |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Faculty of Medicine, Kinki University
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka
Tel
072-366-0221
zizen@med.kindai.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
| 2024 | Year | 07 | Month | 22 | 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
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To collect C-reactive protein (CRP) values at screening in patients with advanced gastric or oesophagogastric junction cancer with MSI-H in the NO LIMIT study and calculate the Glasgow Prognostic Score to assess its usefulness in predicting treatment response (WJOG18624G) for nivolumab in combination with low-dose ipilimumab To investigate the usefulness of nivolumab plus low-dose ipilimumab in predicting treatment response (WJOG18624G)
Management information
Registered date
| 2024 | Year | 07 | Month | 22 | Day |
Last modified on
| 2025 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062878
