UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056281 |
|---|---|
| Receipt number | R000064302 |
| Scientific Title | A biomarker research of "CapeOX or SOX plus zolbetuximab in HER2-negative and CLDN18.2-positive unresectable advanced recurrent gastric or oesophagogastric junction cancer: Randomised, non-comparative phase II clinical trial JACCRO GC-12 (C-SOLVE trial)" |
| Date of disclosure of the study information | 2024/11/27 |
| Last modified on | 2025/05/30 11:55:20 |
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Basic information
Public title
A biomarker research of "CapeOX or SOX plus zolbetuximab in HER2-negative and CLDN18.2-positive unresectable advanced recurrent gastric or oesophagogastric junction cancer: Randomised, non-comparative phase II clinical trial JACCRO GC-12 (C-SOLVE trial)"
Acronym
JACCRO GC-12AR
Scientific Title
A biomarker research of "CapeOX or SOX plus zolbetuximab in HER2-negative and CLDN18.2-positive unresectable advanced recurrent gastric or oesophagogastric junction cancer: Randomised, non-comparative phase II clinical trial JACCRO GC-12 (C-SOLVE trial)"
Scientific Title:Acronym
JACCRO GC-12AR
Region
| Japan |
Condition
Condition
HER2-negative, CLDN18.2-positive unresectable advanced recurrent gastric or oesophagogastric junction cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate and explore biomarkers previously reported to be associated with the therapeutic efficacy of chemotherapy for gastric cancer, as well as biomarkers potentially involved in the efficacy and adverse events of zolbetuximab, in patients enrolled in the JACCRO GC-12 (C-SOLVE) trial
Basic objectives2
Others
Basic objectives -Others
Assoiation between biomarkers and treatment efficacy
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Associations between treatment efficacy and evaluated biomarkers.
Key secondary outcomes
Associations between adverse events and evaluated biomarkers.
Changes in major biomarkers before, during, and after treatment discontinuation.
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) Patients who meet all the eligibility criteria and none of the exclusion criteria for JACCRO GC-12 (C-SOLVE trial).
(2) Among the cases consenting to participate in the JACCRO GC-12 (C-SOLVE) trial, those who have received a thorough explanation of the study details and have provided written informed consent.
Key exclusion criteria
(1) Cases in which the principal investigator determines that participation in this study is inappropriate.
(2) Cases in which the subject did not consent to the use of his/her specimen for research purposes.
Target sample size
120
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
044-977-8111
ykubota@marianna-u.ac.jp
Public contact
Name of contact person
| 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
044-977-8111
Homepage URL
ykubota@marianna-u.ac.jp
Sponsor or person
Institute
Japan Clinical Cancer Research Organization (JACCRO)
Institute
Department
Personal name
Funding Source
Organization
Japan Clinical Cancer Research Organization (JACCRO)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of St. Marianna University School of Medicine
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki, Kanagawa
Tel
044-977-8111
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
聖マリアンナ医科大学病院（神奈川県）他
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 27 | 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
| 2024 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to evaluate and explore biomarkers previously reported to be associated with the therapeutic efficacy of chemotherapy for gastric cancer, as well as biomarkers potentially involved in the efficacy and adverse events of zolbetuximab, in patients enrolled in the JACCRO GC-12 (C-SOLVE) trial.
Management information
Registered date
| 2024 | Year | 11 | Month | 27 | Day |
Last modified on
| 2025 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064302
