UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054917 |
|---|---|
| Receipt number | R000061481 |
| Scientific Title | Prediction of therapeutic effect of immune checkpoint inhibitors by early PET-CT evaluation in esophageal cancer |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/07/09 16:48:01 |
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Basic information
Public title
Prediction of therapeutic effect of immune checkpoint inhibitors by early PET-CT evaluation in esophageal cancer
Acronym
Prediction of therapeutic effect of immune checkpoint inhibitors by early PET-CT evaluation in esophageal cancer
Scientific Title
Prediction of therapeutic effect of immune checkpoint inhibitors by early PET-CT evaluation in esophageal cancer
Scientific Title:Acronym
Prediction of therapeutic effect of immune checkpoint inhibitors by early PET-CT evaluation in esophageal cancer
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the role of PET-CT as a predictive marker of therapeutic response to Nivolumab, Ipilimumab+Nivolumab, FP+Pembrolizumab/Nivolumab and Pembrolizumab in unresectable advanced or recurrent esophageal cancer.
Basic objectives2
Others
Basic objectives -Others
Association of ICI treatment efficacy and adverse events with changes in FDG accumulation (SUVmax) in intra- and extra-regional non-metastatic lymph nodes on PET-CT
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between ICI best treatment effect and changes in FDG accumulation (SUVmax) in regional non-metastatic lymph nodes on PET-CT
Key secondary outcomes
Overall survival (OS), progression-free survival (PFS), treatment success time (TTF), response rate, disease control rate, and adverse events including irAEs after ICI treatment in relation to changes in FDG accumulation in intra- and extra-regional lymph nodes (non-metastatic and metastatic) and in various organs (lung, thyroid, pancreas, adrenal, etc.) where irAEs can occur
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
PET-CT imaging 8 days after administration of immune checkpoint inhibitors
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with unresectable advanced or recurrent esophageal squamous cell carcinoma scheduled to receive immune checkpoint inhibitors
Key exclusion criteria
1)Patients with cancer other than esophageal cancer at the time of administration of immune checkpoint inhibitors
2)Patients with a history of cancer within 5 years of starting immune checkpoint inhibitor therapy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Doki |
Organization
Osaka University
Division name
Department of Gastroenterological surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita city, Osaka
TEL
0668793251
hmatsuda@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | |
| Last name | Makino |
Organization
Osaka University
Division name
Department of Gastroenterological surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita city, Osaka
TEL
0668793251
Homepage URL
tmakino@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Osaka University Hospital
Address
2-2, Yamadaoka, Suita city, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
| 2024 | Year | 08 | Month | 01 | 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
| 2024 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 09 | Day |
Last modified on
| 2024 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061481
