UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043703 |
|---|---|
| Receipt number | R000049899 |
| Scientific Title | A Prospective Observational Study in Nivolumab Therapy for Advanced or Recurrent Esophageal Squamous Cell Carcinoma after Cancer Chemotherapy |
| Date of disclosure of the study information | 2021/03/22 |
| Last modified on | 2024/04/01 19:56:03 |
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Basic information
Public title
A Prospective Observational Study in Nivolumab Therapy for Advanced or Recurrent Esophageal Squamous Cell Carcinoma after Cancer Chemotherapy
Acronym
ANTARES study
Scientific Title
A Prospective Observational Study in Nivolumab Therapy for Advanced or Recurrent Esophageal Squamous Cell Carcinoma after Cancer Chemotherapy
Scientific Title:Acronym
ANTARES study
Region
| Japan |
Condition
Condition
Advanced or recurrent esophageal squamous cell carcinoma after cancer chemotherapy
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To analyze the efficacy and safety of nivolumab in patients who receive nivolumab for advanced or recurrent esophageal squamous cell carcinoma that is not curatively resectable and has worsened after cancer chemotherapy.
To analyze biomarkers including blood metabolytes and microRNAs derived from gut microbiota using pretreatment fasting peripheral blood and stool samples to explore factors associated with therapeutic efficacy and safety of nivolumab.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between metabolite expression level and therapeutic effects of nivolumab
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age > 20 years
2) ECOG performance status: 0, 1, or 2
3) Histological diagnosis of primary esophageal squamous cell carcinoma
4) Received at least one regimen of chemotherapy and scheduled to receive nivolumab.
5) Diagnosed with advanced or recurrent unresectable esophageal cancer after cancer chemotherapy at the time of enrollment.
6) Patients with evaluable lesions (whether or not lesions are measurable is irrelevant)
7) Informed consent
Key exclusion criteria
1) Active multiple cancer (synchronous multiple cancer or metachronous multiple cancer where patient has been disease-free for less than 3 years)
2) Prior therapy with anti-PD-1 antibodies (e.g., nivolumab, pembrolizumab), anti-PD-L1 antibodies (e.g., Avelumab, Atezolizumab), anti-CTLA-4 antibodies (e.g., Ipilimumab), or other drugs for T-cell regulation.
3) Receipt of systemic corticosteroids (except for temporary use for testing or prophylactic administration) in excess of 10 mg/day of prednisolone equivalent or or immunosuppressive agents within 14 days prior to enrollment.
4) Patients who have received antibiotics within 14 days prior to registration (Topical medications are acceptable).
5) Patients with the following complications or history of complications
a) Complications or history of interstitial lung disease
b) Obvious interstitial shadows on chest imaging
c) Inflammatory changes due to active radiation pneumonia or infectious pneumonia on chest imaging.
d) History of autoimmune disease, or chronic or recurrent autoimmune disease
e) History of organ transplantation (including hematopoietic stem cell transplantation).
f) Active or history of tuberculosis.
6) Patients deemed unsuitable as study subjects by an investigator for any other reason
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Hamamoto |
Organization
Keio University Hospital
Division name
Cancer Center
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
03-5363-3288
yashmmt1971@gmail.com
Public contact
Name of contact person
| 1st name | Kenro |
| Middle name | |
| Last name | Hirata |
Organization
Keio University Hospital
Division name
Cancer Center
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
03-5363-3288
Homepage URL
kenro916@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2021 | Year | 03 | Month | 22 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 03 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049899
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| Registered date | File name |
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| Registered date | File name |
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