UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063314 |
|---|---|
| Receipt number | R000072469 |
| Scientific Title | Association Between Early Dynamics of Chronic Stress and Inflammation and Treatment Response and Mortality in Patients with Unresectable or Advanced Cancer Receiving Immune Checkpoint Inhibitor Therapy: A Multicenter Cohort Study |
| Date of disclosure of the study information | 2026/10/16 |
| Last modified on | 2026/10/16 13:50:24 |
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Basic information
Public title
A Study on Early Stress and Inflammatory Dynamics for Predicting Outcomes in Immune Checkpoint Inhibitor Therapy
Acronym
SIP-ICI Study
Scientific Title
Association Between Early Dynamics of Chronic Stress and Inflammation and Treatment Response and Mortality in Patients with Unresectable or Advanced Cancer Receiving Immune Checkpoint Inhibitor Therapy: A Multicenter Cohort Study
Scientific Title:Acronym
SIP-ICI Study
Region
| Japan |
Condition
Condition
Unresectable and Advanced Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether chronic stress status and early inflammatory dynamics are associated with treatment response and prognosis in unresectable or advanced cancer patients undergoing immune checkpoint inhibitor therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The objective response rate (ORR) at 12 weeks after treatment initiation, comparing ORR between the high risk and non high risk groups defined by the Hospital Anxiety and Depression Scale (HADS)
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
Patients with unresectable or advanced cancer confirmed to be clinically incurable, based on radiologic, histologic, or cytologic assessment.
Patients receiving immune checkpoint inhibitor (ICI) therapy as first line treatment, either as monotherapy or in combination regimens, for metastatic, recurrent, or advanced disease.
Prior surgery or radiotherapy is allowed, but patients who have received ICI as neoadjuvant or adjuvant therapy are excluded.
Presence of evaluable disease according to RECIST version 1.1 measurable disease is not required.
Patients aged 18 years or older, with no restrictions on sex.
ECOG performance status (PS) 0 to 2.
Written informed consent obtained from the patient after adequate explanation of the study prior to enrollment.
Key exclusion criteria
Patients with severe comorbidities, including but not limited to severe infections, major cerebrovascular disease, poorly controlled diabetes, severe cardiac disease, interstitial lung disease or pulmonary fibrosis, active small bowel disease, severe hepatic impairment, or severe renal impairment.
Patients scheduled to receive other forms of immunotherapy.
Patients with synchronous or metachronous multiple malignancies, except for carcinoma in situ of the uterine cervix, adequately treated basal cell carcinoma of the skin, or malignancies treated more than 5 years earlier with no evidence of recurrence.
Patients receiving continuous systemic corticosteroid therapy.
Patients with coexisting autoimmune diseases.
Patients with coexisting psychiatric disorders.
Any patient deemed unsuitable for participation by the treating physician.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Uchino |
Organization
Toranomon Hospital
Division name
Medical Oncology
Zip code
105-8470
Address
2-2-2 Toranomon, Minato City, Tokyo, Japan
TEL
03-3588-1111
keita-u4907@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Uchino |
Organization
Toranomon Hospital
Division name
Medical Oncology
Zip code
105-8470
Address
2-2-2 Toranomon, Minato City, Tokyo, Japan
TEL
03-3588-1111
Homepage URL
keita-u4907@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Federation of National Public Service Personnel Mutual Aid Associations
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
Toranomon Hospital Institutional Review Board
Address
2-2-2 Toranomon, Minato City, Tokyo, Japan
Tel
03-3588-1111
chiken-jim@toranomon.gr.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 | 10 | Month | 16 | 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
| 2026 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No specific remarks
Management information
Registered date
| 2026 | Year | 10 | Month | 16 | Day |
Last modified on
| 2026 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072469
