UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059652 |
|---|---|
| Receipt number | R000068205 |
| Scientific Title | Observational Study on the Abscopal Efect by Ultra-hypofractionated Radiation Therapyin combination with Immune Checkpoint Inhibiters for Metastatic Renal Cell Carcinoma |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/11/09 15:58:01 |
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Basic information
Public title
Observational study to evaluate the systemic effects of radiotherapy in patients with metastatic renal cell carcinoma receiving immunotherapy
Acronym
AURICRE study
Scientific Title
Observational Study on the Abscopal Efect by Ultra-hypofractionated Radiation Therapyin combination with Immune Checkpoint Inhibiters for Metastatic Renal Cell Carcinoma
Scientific Title:Acronym
AURICRE study
Region
| Japan |
Condition
Condition
Renal Cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the clinical and immunological characteristics of the abscopal effect in metastatic renal cell carcinoma patients receiving immunotherapy, and to establish a foundation for combined immunotherapy and ultra-hypofractionated radiotherapy strategies.
Basic objectives2
Others
Basic objectives -Others
To determine the 1-year abscopal response rate in non-irradiated lesions after IGU in patients treated with ICI.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Abscopal response rate (ARR) at 1 year after IGU
Key secondary outcomes
Secondary Endpoints
1. Tumor shrinkage rate of irradiated and non-irradiated lesions at each assessment time point during follow-up
2. 1-year overall survival (OS)
3. 1-year disease-specific survival (DSS)
4. 1-year progression-free survival (PFS)
Exploratory Endpoint
1. To evaluate the association between treatment response and changes in circulating cytokine levels before and after IGU
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. Patients aged 18 years and above with metastatic renal cell carcinoma
2. Patients currently receiving immune checkpoint inhibitor (ICI) therapy who are assessed as having iCPD or iSD according to iRECIST
3. Presence of two or more clinically measurable lesions (assessed by CT, MRI, physical examination, or visual inspection)
Note: Osteosclerotic lesions without measurable soft-tissue components are excluded
4. Planned to undergo IGU to the target lesion
5. Provided written informed consent after receiving sufficient explanation of this study
Note: Proxy signature is permitted if the patient is physically unable to sign
Key exclusion criteria
1. Patients with active double cancers
(synchronous double cancers or metachronous double cancers with a disease-free interval within 2 years).
However, carcinoma in situ or intramucosal carcinoma considered cured by treatment, and the following tumors even if within 2 years of disease-free interval are not excluded: gastric cancer stage 0-II (UICC), prostate cancer stage I-III, colorectal cancer stage 0-II, esophageal cancer stage 0-I, breast cancer stage 0-II, endometrial cancer stage I-II, cervical cancer stage 0-II, and thyroid cancer stage I-III. In addition, any cancer with a disease-free interval greater than 2 years is not excluded regardless of stage.
2. Patients with serious comorbidities, such as:
- severe cardiac disease
- uncontrolled diabetes mellitus despite continuous insulin therapy
- myocardial infarction within 6 months
- uncontrolled hypertension
- active infections (bacterial, viral, or fungal)
- diarrhea (watery stool), paralytic ileus, or bowel obstruction
- autoimmune disease
- any other severe comorbid condition
3. Patients with clear evidence of idiopathic interstitial pneumonia (usual interstitial pneumonia pattern) on chest X-ray or CT
4. Patients with acute-phase pneumonia
5. Patients with psychiatric disorders or psychiatric symptoms judged to make study participation difficult
Target sample size
145
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Onishi |
Organization
Faculty of Medicine, University of Yamanashi
Division name
Department of Therapeutic Radiology
Zip code
409-3898
Address
1110, Shimokato, Chuo, Yamanashi, 409-3898 Japan
TEL
055-273-1111
honishi@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Zhe |
| Middle name | |
| Last name | Chen |
Organization
Faculty of Medicine, University of Yamanashi
Division name
Department of Therapeutic Radiology
Zip code
409-3898
Address
1110, Shimokato, Chuo, Yamanashi, 409-3898 Japan
TEL
055-273-1111
Homepage URL
chenzhe@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT), Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Yamanashi Ethics Committee
Address
1110, Shimokato, Chuo, Yamanashi, 409-3898 Japan
Tel
055-273-1111
rec-med@yamanashi.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 | 11 | Month | 10 | 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 | 08 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter observational study.
Central IRB approval at University of Yamanashi; local approvals at each site.
No additional intervention beyond standard care.
Management information
Registered date
| 2025 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068205
