UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058372 |
|---|---|
| Receipt number | R000066733 |
| Scientific Title | Efficacy of immune checkpoint inhibitors in patients with MSI-H/dMMR small bowel adenocarcinoma |
| Date of disclosure of the study information | 2025/07/07 |
| Last modified on | 2026/02/24 21:56:54 |
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Basic information
Public title
Efficacy of immune checkpoint inhibitors in patients with MSI-H/dMMR small bowel adenocarcinoma
Acronym
Efficacy of immune checkpoint inhibitors in patients with MSI-H/dMMR small bowel adenocarcinoma
Scientific Title
Efficacy of immune checkpoint inhibitors in patients with MSI-H/dMMR small bowel adenocarcinoma
Scientific Title:Acronym
Efficacy of immune checkpoint inhibitors in patients with MSI-H/dMMR small bowel adenocarcinoma
Region
| Japan |
Condition
Condition
MSI-H/dMMR small bowel adenocarcinoma
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Meta-analysis of the efficacy of immune checkpoint inhibitors in MSI-H/dMMR small bowel adenocarcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective response rate of immune checkpoint inhibitors in MSI-H/dMMR small bowel adenocarcinoma
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
(1) The search terms include "small bowel adenocarcinoma", "non-colorectal", "solid tumor", "MSI-H", "dMMR", "immunotherapy", "immune checkpoint", "programmed cell death protein 1", "programmed cell death ligand 1 inhibitor", "PD-1" and "PD-L1".
(2) Single-arm Phase I-III clinical trials evaluating immunotherapy in patients with advanced SBA or solid tumors, reporting objective response rates or treatment outcomes for individual patients.
Key exclusion criteria
(1) Observational or retrospective studies.
(2) Systematic review or meta-analysis studies.
(3) Studiers published in languages other than English.
(6) Conference abstracts.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Nakashima |
Organization
Toyohashi Municipal Hospital
Division name
Department of General Surgery
Zip code
4418570
Address
50 Hachiken-nishi, Aotake-cho, Toyohashi, Aichi, Japan.
TEL
81-532-33-6111
nakashima-yu@toyohashi-mh.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Nakashima |
Organization
Toyohashi Municipal Hospital
Division name
Department of General Surgery
Zip code
4418570
Address
50 Hachiken-nishi, Aotake-cho, Toyohashi, Aichi, Japan.
TEL
81-532-33-6111
Homepage URL
nakashima-yu@toyohashi-mh.jp
Sponsor or person
Institute
Toyohashi Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Not applicable.
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
Not applicable.
Address
Not applicable.
Tel
0
0
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 | 07 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://dx.doi.org/10.1080/1750743X.2026.2626236
Number of participants that the trial has enrolled
72
Results
10 studies comprising a total of 72 patients with MSI H/dMMR SBA were included in this brief meta-analysis. The patient population consisted of patients with SBA in two trials and MSI H/dMMR solid tumors in eight trials. All the included trials enrolled patients with unresectable tumors due to locally advanced or metastatic disease. Ten studies comprising 72 patients evaluated the efficacy of ICIs for MSI H/dMMR SBA showed a pooled objective response rate of 65.3% (95% CI: 48.0%~82.3%).
Results date posted
| 2026 | Year | 02 | Month | 24 | Day |
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
Completed
Date of protocol fixation
| 2025 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This meta-analysis aims to identify clinical trials of immune checkpoint inhibitors for small bowel cancer published up to December 2024 through database searches. Treatment outcomes will be pooled and analyzed using a random-effects model.
Management information
Registered date
| 2025 | Year | 07 | Month | 05 | Day |
Last modified on
| 2026 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066733
