UMIN-ICDS Clinical Trial

Public title

Skeletal muscle-based treatment strategies for immune checkpoint inhibitor

Acronym

Skeletal muscle-based treatment strategies for immune checkpoint inhibitor

Scientific Title

Skeletal muscle-based treatment strategies for immune checkpoint inhibitor

Scientific Title:Acronym

Skeletal muscle-based treatment strategies for immune checkpoint inhibitor

Region

Japan

Condition

Urothelial carcinoma

Classification by specialty

Hematology and clinical oncology

Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We investigated patients with urothelial carcinoma receiving treatment with immune checkpoint inhibitors, focusing on: (1) body composition related to sarcopenia (such as skeletal muscle mass, muscle strength, and muscle quality), (2) skeletal muscle-related factors involved in immune regulation; (3) immune status related to resistance to ICI therapy (rate of increase in CD8+ T cells following treatment, proportion of regulatory T cells and bone marrow-derived suppressor cells, expression of immune checkpoint molecules on CD8+ T cells, etc.); and (4) ICI treatment outcomes (treatment efficacy, adverse effects, etc.), with the aim of clarifying the relationships among these factors.

Basic objectives2

Others

Basic objectives -Others

To elucidate the relationship between body composition factors associated with sarcopenia (such as skeletal muscle mass, muscle strength, and muscle quality) and immune status factors associated with resistance to ICI therapy (such as the rate of increase in CD8+ T cells following treatment, the proportion of regulatory T cells and bone marrow-derived suppressor cells, and the expression of immune checkpoint molecules on CD8+ T cells)

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The relationship between body composition associated with sarcopenia and serum concentrations of skeletal muscle-related factors

Key secondary outcomes

The relationship between body composition associated with sarcopenia and immune status and immune function
The relationship between body composition associated with sarcopenia and treatment outcomes
The relationship between blood-based immune status and treatment outcomes
The relationship between skeletal muscle-related factors and treatment outcomes
The relationship between blood concentrations of skeletal muscle-related factors and immune status
The effects of serum from sarcopenia patients and skeletal muscle-related factors on immune cells

Treatment outcomes include treatment completion rate, duration of treatment, adverse events, overall survival, progression-free survival, best response, reasons for treatment discontinuation, occurrence of unscheduled visits, occurrence of unscheduled hospitalizations, relative dose intensity, and changes in quality of life (QOL).

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients starting treatment with immune checkpoint inhibitors
Patients diagnosed with urothelial carcinoma
Patients who have provided informed consent to participate in this study by signing a consent form
Patients aged 18 years or older

Key exclusion criteria

Individuals from whom written consent could not be obtained
Other patients deemed unsuitable by the attending physician

Target sample size

90

Name of lead principal investigator

1st name	Tatsuya
Middle name
Last name	Yagi

Organization

Hamamatsu University School of Medicine, University Hospital

Division name

Department of hospital pharmacy

Zip code

431-3192

Address

1-20-1 Handayama, Chuo-Ku, Hamamatsu, 431-3192, Japan.

TEL

0534352767

Email

yagi5922@hama-med.ac.jp

Name of contact person

1st name	Sumika
Middle name
Last name	Osa

Organization

Hamamatsu University School of Medicine, University Hospital

Division name

Department of hospital pharmacy

Zip code

431-3192

Address

1-20-1 Handayama, Chuo-Ku, Hamamatsu, 431-3192, Japan.

TEL

0534352767

Homepage URL

Email

osa.su@hama-med.ac.jp

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Hamamatsu University School of Medicine

Address

1-20-1 Handayama, Chuo-Ku, Hamamatsu, 431-3192, Japan.

Tel

0534352111

Email

rinri@hama-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

04

Month

10

Day

Date of IRB

Anticipated trial start date

2026

Year

06

Month

01

Day

Last follow-up date

2030

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Items to be Collected as Data
Subject Background: Name, age, sex, diagnosis, disease stage, distant metastasis, presence and severity of cancer cachexia, medical history, comorbidities, lifestyle history, concomitant medications, medication adherence, treatment regimen, treatment history, dosage, dose intensity, performance status
Physical Findings: Height, weight, body surface area, BMI, blood pressure, pulse, body temperature
Laboratory Tests: Hematological tests (white blood cell count, hemoglobin level, platelet count, neutrophil count, lymphocyte count, etc.), Biochemical tests (AST, ALT, ALP, total bilirubin, albumin, CRP, BUN, creatinine, eGFR, cystatin-C, blood glucose, HbA1c, NT-proBNP, electrolytes, etc.)
Treatment Outcomes (Duration of treatment, Reason for discontinuation, Dose reduction (yes/no), Reason for dose reduction, Overall survival, Progression-free survival, Duration of response, Best response, etc.)
Adverse events (nausea, vomiting, loss of appetite, taste disturbance, oral mucositis, fatigue, constipation, diarrhea, skin reactions, hand-foot syndrome, alopecia, peripheral neuropathy, joint pain, muscle pain, edema, infusion reactions, irAEs, leukopenia, neutropenia, thrombocytopenia, anemia, febrile neutropenia, etc.)
Sarcopenia diagnosis (AWGS2019)
Geriatric assessment tools (Geriatric-8, VES-13, CARG score)
QOL score (EORTC QLQ-C30)
Body composition analysis (body weight, BMI, skeletal muscle mass, skeletal muscle mass index, body fat mass, phase angle, etc.)
Grip strength
Blood biomarkers (amino acids, IL-15, IL-6, IL-8, Activin A, Irisin, SPARC, myostatin, etc.)
Peripheral blood immune cells (regulatory T cells, bone marrow-derived suppressor cells, NK cells, CD8-positive T cells, etc.)
Other (presence of unscheduled outpatient visits, presence of unscheduled hospitalizations, length of hospital stay)
Residual blood from routine clinical blood draws, or blood collected via additional draws

Registered date

2026

Year

04

Month

17

Day

Last modified on

2026

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070054