UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059075 |
|---|---|
| Receipt number | R000067565 |
| Scientific Title | Randomized Phase II trial Evaluating the Efficacy of ZolbEtuximab in the second-line for CLaudin18.2 Positive AdvanceD GAstric/EGJ Cancer Patients Previously Treated with Zolbetuximab and Platinum-Based Chemotherapy (ZELDA trial):Translational Biomarker Research (ZELDA-TR trial) |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/12 16:50:42 |
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Basic information
Public title
Randomized Phase II trial Evaluating the Efficacy of ZolbEtuximab in the second-line for CLaudin18.2 Positive AdvanceD GAstric/EGJ Cancer Patients Previously Treated with Zolbetuximab and Platinum-Based Chemotherapy (ZELDA trial):Translational Biomarker Research (ZELDA-TR trial)
Acronym
ZELDA-TR trial
Scientific Title
Randomized Phase II trial Evaluating the Efficacy of ZolbEtuximab in the second-line for CLaudin18.2 Positive AdvanceD GAstric/EGJ Cancer Patients Previously Treated with Zolbetuximab and Platinum-Based Chemotherapy (ZELDA trial):Translational Biomarker Research (ZELDA-TR trial)
Scientific Title:Acronym
ZELDA-TR trial
Region
| Japan |
Condition
Condition
gastric cancer and esophagogastric junction (EGJ) cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This translational research will perform exploratory and confirmatory analyses in patients enrolled in the ZELDA trial to investigate factors potentially associated with the efficacy and adverse events of chemotherapy involving zolbetuximab.
Basic objectives2
Others
Basic objectives -Others
exploratory validation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between CLDN18.2 expression before the start of protocol treatment and therapeutic efficacy
Key secondary outcomes
Relationship between CAV-1 expression and its variation over time and therapeutic efficacy
Relationship between CLDN18.2 expression and its variation over time and treatment course
Relationship between CLDN18.2 expression and its variation over time and CLDN18-ARHGAP fusion
Relationship between CLDN18.2 expression and plasma measurement factors that are measured
Association of liquid-based DNA methylation signatures and liquid-based gene alterations with plasma proteins
Association of liquid-based DNA methylation signature and liquid-based gene alterations that measures before treatment initiation with treatment response
Association of liquid-based DNA methylation signatures that measures before treatment initiation and adverse events
Association between liquid-based DNA methylation signatures before and during treatment initiation and liquid-based gene alterations
Association between changes in plasma DNA methylation signature before and during treatment initiation and the course of treatment
Comparison of liquid-based DNA methylation signatures, liquid-based gene alterations and plasma proteins measured over time to investigate resistance mechanisms
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who have consented to the ZELDA study and who have provided their written consent for the study after receiving sufficient explanation regarding the content of this study.
Key exclusion criteria
(1) Subjects whose participation in this study is judged inappropriate by the investigator.
(2) Subjects who did not consent to use their samples in the study.
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Oki |
Organization
Kyushu University Hospital
Division name
Department of Advanced Medicine and Innovative Technology
Zip code
812-8582
Address
Maidashi 3-1-1, Higashi-Ku, Fukuoka 812-8582, Japan.
TEL
092-642-5631
oki.eiji.857@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Chiaki |
| Middle name | |
| Last name | Inagaki |
Organization
Kindai University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
589-8511
Address
377-2 Ohnohigashi, Osakasayama, Osaka
TEL
072-366-0221
Homepage URL
chiaki_inagaki@med.kindai.ac.jp
Sponsor or person
Institute
Kyushu Studygroup of Clinical Cancer
Institute
Department
Personal name
Funding Source
Organization
Kyushu Studygroup of Clinical Cancer
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
Kyushu University Institutional Review Board for Observational Studies, Faculty of Medical Sciences
Address
Maidashi 3-1-1, Higashi-Ku, Fukuoka 812-8582, Japan.
Tel
092-641-1151
byssien@jimu.kyushu-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 | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
biomarker exploration
Management information
Registered date
| 2025 | Year | 09 | Month | 12 | Day |
Last modified on
| 2025 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067565
