UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059965 |
|---|---|
| Receipt number | R000068587 |
| Scientific Title | Multicenter Retrospective Observational Study on Treatment Outcomes of Chemotherapy Combined with Zolbetuximab for Unresectable Advanced or Recurrent Gastric Cancer |
| Date of disclosure of the study information | 2025/12/04 |
| Last modified on | 2025/12/04 11:25:09 |
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Basic information
Public title
Multicenter Retrospective Observational Study on Treatment Outcomes of Chemotherapy Combined with Zolbetuximab for Unresectable Advanced or Recurrent Gastric Cancer
Acronym
HGCSG2501
Scientific Title
Multicenter Retrospective Observational Study on Treatment Outcomes of Chemotherapy Combined with Zolbetuximab for Unresectable Advanced or Recurrent Gastric Cancer
Scientific Title:Acronym
HGCSG2501
Region
| Japan |
Condition
Condition
Unresectable advanced or recurrent gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the adverse events and treatment outcomes of solutaximab combination therapy for unresectable advanced or recurrent gastric or gastroesophageal junction cancer that is HER2-negative and CLDN18.2-positive in actual clinical practice in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Key secondary outcomes
OS, PFS, TTF, best overall response, treatment response predictors, prognostic predictors
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients pathologically diagnosed with unresectable advanced or recurrent gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
2) Patients confirmed to be HER2-negative and CLDN18.2-positive by pathology
3) Patients who received zolbeximab in combination with fluoropyrimidine antineoplastic agents (5-FU, S-1, capecitabine) and oxaliplatin (cases where administration of other agents was not possible after zolbeximab due to adverse events, etc., despite planned combination therapy are acceptable). Treatment line is not restricted.
4) Patients aged 20 years or older at diagnosis
5) Patients who did not refuse participation in this study
Key exclusion criteria
1) Patients who received combination therapy with fluoropyrimidine antineoplastic agents (5-FU, S-1, capecitabine) or antineoplastic agents other than oxaliplatin and solubeximab, regardless of the route of administration
2) Other patients deemed unsuitable for inclusion in the study by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshito |
| Middle name | |
| Last name | Komatsu |
Organization
Hokkaido University Hospital
Division name
Tumor Center
Zip code
060-8648
Address
Kita14,Nishi5,Kita- Ku,Sapporo,Hokkaido
TEL
011-716-1161
ykomatsu@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Kazuaki |
| Middle name | |
| Last name | Harada |
Organization
Hokkaido University Hospital
Division name
Tumor Center
Zip code
060-8648
Address
Kita14,Nishi5,Kita- Ku,Sapporo,Hokkaido
TEL
011-716-1161
Homepage URL
haraharaccho0605@yahoo.co.jp
Sponsor or person
Institute
Hokkaido Gastrointestinal Cancer Chemotherapy Study Group
Institute
Department
Personal name
Funding Source
Organization
self-procurement
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita14,Nishi5,Kita- Ku,Sapporo,Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.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 | 04 | 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 | 21 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Investigating patient background, administration status, efficacy, and safety during the treatment period
Management information
Registered date
| 2025 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068587
