UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060223 |
|---|---|
| Receipt number | R000068885 |
| Scientific Title | Investigation of gastric cancer treatment using zolbetuximab |
| Date of disclosure of the study information | 2025/12/28 |
| Last modified on | 2025/12/28 21:06:30 |
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Basic information
Public title
Investigation of gastric cancer treatment using zolbetuximab
Acronym
Study of Zolbetuximab in Gastric Cancer
Scientific Title
Investigation of gastric cancer treatment using zolbetuximab
Scientific Title:Acronym
Zolbetuximab Gastric Analysis 1
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of factors associated with the therapeutic effect of zolbetuximab
Basic objectives2
Others
Basic objectives -Others
Correlation between biomarker expression and therapeutic effect
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Protein expression of CLDN18.2, CDH1, and others in tumor tissues (From the date of IRB approval to March 31, 2027)
Key secondary outcomes
Correlation analysis between protein expression and patient characteristics (age, sex, metastatic organs) and clinical course, including retrospective cases.
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
Patients with gastric cancer who have received chemotherapy
Key exclusion criteria
Patients judged ineligible for the study by the investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shuhei |
| Middle name | |
| Last name | Suzuki |
Organization
Yamagata Prefectural Shinjo Hospital
Division name
Internal Medicine
Zip code
996-8585
Address
Kanazawa 720-1, Shinjo, Yamagata
TEL
0233-22-5525
s-suzuki@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Shuhei |
| Middle name | |
| Last name | Suzuki |
Organization
Yamagata Prefectural Shinjo Hospital
Division name
Internal Medicine
Zip code
996-8585
Address
Kanazawa 720-1, Shinjo, Yamagata
TEL
0233-22-5525
Homepage URL
s-suzuki@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata Prefectural Shinjo Hospital
Institute
Department
Personal name
Shuhei Suzuki
Funding Source
Organization
Self funding
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
Yamagata Prefectural Shinjo Hospital IRB
Address
Kanazawa 720-1, Shinjo, Yamagata
Tel
0233-22-5525
s-suzuki@med.id.yamagata-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
| 2025 | Year | 12 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study evaluating the correlation between biomarker expression and clinical course using clinical data and samples.
Management information
Registered date
| 2025 | Year | 12 | Month | 28 | Day |
Last modified on
| 2025 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068885
