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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043703
Receipt No. 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 2021/03/22

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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
Email 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
Email kenro916@gmail.com

Sponsor
Institute Keio University
Institute
Department

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
Email 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 Preinitiation
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
2021 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049899

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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