UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023324 |
|---|---|
| Receipt number | R000026876 |
| Scientific Title | Exploratory study to determine S-588410-induced tumor infiltrating lymphocytes and changes in the tumor microenvironment in esophageal cancer patients |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2023/11/10 12:27:24 |
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Basic information
Public title
Exploratory study to determine S-588410-induced tumor infiltrating lymphocytes and changes in the tumor microenvironment in esophageal cancer patients
Acronym
Exploratory study to determine S-588410-induced tumor infiltrating lymphocytes and changes in the tumor microenvironment in esophageal cancer patients
Scientific Title
Exploratory study to determine S-588410-induced tumor infiltrating lymphocytes and changes in the tumor microenvironment in esophageal cancer patients
Scientific Title:Acronym
Exploratory study to determine S-588410-induced tumor infiltrating lymphocytes and changes in the tumor microenvironment in esophageal cancer patients
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of S-588410 on the number of the tumor-infiltrating CD8-positive lymphocytes in the esophagus tissue
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Tumor-infiltrating CD8-positive lymphocytes
Key secondary outcomes
Cytotoxic T cell
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
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
S-588410 will be injected subcutaneously once weekly, 5 times or more in total.
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
1)Patients who are male or female aged 20 years or more at the time of informed consent.
2)Patients who are willing to supply the tumor tissue
3)Patients with esophagus squamous cell carcinoma or adenocarcinoma histologically
4)HLA-A*24:02-positive patients
5)The patient who can initiate the administration of the test drug more than 30 days before the esophagus resection
Key exclusion criteria
1)The patient who are going to receive or received the following treatment for the primary disease
/Antineoplastic drug
/Radiotherapy
/Thermotherapy
/Systemic immunosuppressant
/immunotherapy
2)Patients with uncontrolled systemic or active infection.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hatanaka |
| Middle name | |
| Last name | Kazuhiro |
Organization
Shionogi & Co., Ltd.
Division name
Global Development
Zip code
541-0045
Address
1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan
TEL
06-6209-7885
shionogiclintrials-admin@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Kyokawa |
| Middle name | |
| Last name | Yoshimasa |
Organization
Shionogi & Co., Ltd.
Division name
Corporate Communications Department
Zip code
541-0045
Address
1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan
TEL
06-6209-7885
Homepage URL
shionogiclintrials-admin@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
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
National Cancer Center IRB
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
irboffice@east.ncc.go.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
| 2016 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
See URL related to results and publications
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00262-020-02619-3
Number of participants that the trial has enrolled
15
Results
The tumor infiltrating CD8-positive lymphocyte density in esophageal cancer tissues increased from baseline.
Results date posted
| 2023 | Year | 11 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 06 | Month | 04 | Day |
Baseline Characteristics
The study was conducted in HLA-A*24:02-positive patients with esophageal cancer.
Participant flow
Fifteen participants were enrolled.
Adverse events
Treatment-emergent adverse events (TEAEs) occurred in 80.0% of enrolled participants. The most frequent TEAE was injection site reaction with grade 1 or 2. The other TEAEs were reported only each in 1 patient.
Outcome measures
For number of tumor-infiltrating CD8-positive lymphocytes, the mean percent change from baseline (standard deviation) (N=14) was 175.54 (178.37)%.
Number of patients who showed Cytotoxic T cell induction to at least one of the antigens was 15 of 15 patients.
Plan to share IPD
Not determined
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 25 | Day |
Last modified on
| 2023 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026876
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