UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062598 |
|---|---|
| Receipt number | R000071239 |
| Scientific Title | Multicenter Prospective Observational Study of the Safety and Efficacy of ICI Rechallenge After Severe ICI-Induced Liver Injury |
| Date of disclosure of the study information | 2026/08/18 |
| Last modified on | 2026/08/18 09:58:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multicenter Prospective Observational Study of Immune Checkpoint Inhibitor Rechallenge After Recovery From Severe ICI-Induced Liver Injury
Acronym
ICI-Liver Injury Rechallenge Study
Scientific Title
Multicenter Prospective Observational Study of the Safety and Efficacy of ICI Rechallenge After Severe ICI-Induced Liver Injury
Scientific Title:Acronym
ICI-Liver Injury Rechallenge Study
Region
| Japan |
Condition
Condition
Patients with malignancies who experienced Grade 3 or higher immune checkpoint inhibitor-induced liver injury
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively follow patients who have recovered from Grade 3 or higher ICI-induced liver injury and undergo ICI rechallenge as part of routine clinical care, and to evaluate the recurrence rate of Grade 2 or higher ICI-induced liver injury within 6 months after rechallenge, the severity of recurrent liver injury, other immune-related adverse events, and antitumor efficacy. The study will also explore factors associated with the risk of liver injury recurrence using clinical data, blood biomarkers, and liver biopsy findings.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Recurrence rate of Grade 2 or higher ICI-induced liver injury within 6 months after ICI rechallenge
Key secondary outcomes
Severity of recurrent ICI-induced liver injury after ICI rechallenge
Immunosuppressive treatment for recurrent ICI-induced liver injury
Incidence of immune-related adverse events involving organs other than the liver after ICI rechallenge
Objective response rate
Disease control rate
Duration of treatment after ICI rechallenge
Reasons for treatment discontinuation
Progression-free survival
Overall survival
Clinical factors associated with the risk of recurrent ICI-induced liver injury
Exploratory biomarker analyses using blood samples and existing liver biopsy specimens
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) Age 18 years or older
2) History of ICI treatment for a malignant tumor
3) Recovery after grade 3 or higher ICI-induced liver injury
4) The treating physician or clinical team has carefully assessed the risks and benefits and determined that ICI retreatment is clinically appropriate
Key exclusion criteria
Patients who do not provide written informed consent to participate in the study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Ito |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8560
Address
9th Floor, Medical Science Research Building 1, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560, Japan
TEL
052-744-2169
ito.takanori.d9@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Mizuno |
Organization
Nagoya University Hospital
Division name
Department of Clinical Oncology and Chemotherapy
Zip code
466-8560
Address
9th Floor, Medical Science Research Building 1, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
052-744-2169
Homepage URL
mizuno.kazuyuki.g2@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Takeda Science Foundation
IRB Contact (For public release)
Organization
Bioethics Review Committee, Nagoya University Graduate School of Medicine and School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
Tel
052-744-2423
iga-shinsa@t.mail.nagoya-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
| 2026 | Year | 08 | Month | 18 | 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 | 11 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2031 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2032 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2032 | Year | 12 | Month | 31 | Day |
Other
Other related information
This is a multicenter prospective cohort-type observational study. ICI retreatment is not assigned by the study protocol; independently of study participation, the treating physician or clinical team determines retreatment as part of routine clinical care after assessing the risks and benefits. During the three-year enrollment period, consecutive eligible patients who provide written informed consent at participating institutions will be registered. Patients will be prospectively followed using REDCap. Collected data will include patient characteristics, malignancy and treatment history, initial ICI treatment, onset, severity and management of the initial liver injury, type and timing of ICI retreatment, laboratory findings, recurrent liver injury, other immune-related adverse events, antitumor response, progression-free survival and overall survival. With additional consent, blood samples will be obtained before retreatment and at recurrence of liver injury for exploratory analyses of inflammatory cytokines and chemokines, immune-related proteins, autoantibodies, immunoglobulins and immune-cell subsets. Existing liver biopsy specimens obtained for clinical purposes may also be analyzed to explore pathologic predictors of recurrence.
Management information
Registered date
| 2026 | Year | 08 | Month | 18 | Day |
Last modified on
| 2026 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071239
