UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059987 |
|---|---|
| Receipt number | R000067981 |
| Scientific Title | A Prospective Observational Study on the Dynamics of Claudin18.2, PD-L1, and HER2 Expression Following First-Line Treatment in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. |
| Date of disclosure of the study information | 2025/12/05 |
| Last modified on | 2025/12/05 09:29:01 |
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Basic information
Public title
A Prospective Observational Study on the Dynamics of Claudin18.2, PD-L1, and HER2 Expression Following First-Line Treatment in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.
Acronym
A Prospective Observational Study on the Dynamics of Claudin18.2, PD-L1, and HER2 Expression Following First-Line Treatment in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.
Scientific Title
A Prospective Observational Study on the Dynamics of Claudin18.2, PD-L1, and HER2 Expression Following First-Line Treatment in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.
Scientific Title:Acronym
A Prospective Observational Study on the Dynamics of Claudin18.2, PD-L1, and HER2 Expression Following First-Line Treatment in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.
Region
| Japan |
Condition
Condition
To investigate the potential usefulness of zolbetuximab, primarily as a second-line or later treatment, by evaluating changes in key biomarkers, including Claudin 18.2 (CLDN18.2), before and after first-line treatment for unresectable gastric cancer and gastroesophageal junction cancer.
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the potential usefulness of zolbetuximab, primarily as a second-line or later treatment, by evaluating changes in key biomarkers, including Claudin 18.2 (CLDN18.2), before and after first-line treatment for unresectable gastric cancer and gastroesophageal junction cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in CLDN18.2 expression before and after first-line treatment
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Unresectable gastric cancer or gastroesophageal junction cancer
(2)Histologically confirmed adenocarcinoma
(3)CLDN18.2, PD-L1 CPS (22C3), and HER2 status are known before the start of first-line treatment
(4)There is a Primary tumor
(5)Patients currently undergoing any of the following first-line treatments, or whose first-line treatments have been discontinued due to reactivity, intolerance, or patient preference:
A.Zolbetuximab-containing chemotherapy* for HER2-negative and CLDN18.2-positive patients
B.Anti-PD-1 antibody-containing chemotherapy* for HER2-negative and CLDN18.2-negative patients
C.Trastuzumab-containing chemotherapy* for HER2-positive patients (including chemotherapy + trastuzumab + pembrolizumab)
*Chemotherapy: Fluoropyrimidine preparations + platinum
(6)Patients scheduled for upper gastrointestinal endoscopy and biopsy for the purpose of primary tumor evaluation, etc., upon discontinuation of first-line treatment
Key exclusion criteria
(1)Cases in which the treatment period (start date to stop date) of first-line treatment is less than 6 weeks
(2)Cases in which second-line treatment has already begun
(3)Cases in which the subject did not consent to the use of his/her specimen for research purposes.
(4)Cases in which the principal investigator determines that participation in this study is inappropriate.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Kubota |
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
TEL
0449778111
ykubota@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Manami |
| Middle name | |
| Last name | Onoue |
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
TEL
0449778111
Homepage URL
manami1o@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
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
IRB, St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel
0449778111
k-sienbu.mail@marianna-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 | 05 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The primary endpoint of this study was the change in CLDN18.2 expression before and after first-line treatment for unresectable gastric cancer and gastroesophageal junction cancer. The study primarily examines the potential usefulness of zolbetuximab as second-line or later treatment.
Management information
Registered date
| 2025 | Year | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067981
