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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007905
Receipt No. R000009311
Scientific Title A randomized multicenter trial of adjuvant IMF-001 after curative resection for esophageal cancer with NY-ESO-1 antigen (phase II study)
Date of disclosure of the study information 2012/05/14
Last modified on 2018/05/14

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Basic information
Public title A randomized multicenter trial of adjuvant IMF-001 after curative resection for esophageal cancer with NY-ESO-1 antigen (phase II study)
Acronym A randomized multicenter trial of adjuvant IMF-001 after curative resection for esophageal cancer with NY-ESO-1 antigen (phase II study)
Scientific Title A randomized multicenter trial of adjuvant IMF-001 after curative resection for esophageal cancer with NY-ESO-1 antigen (phase II study)
Scientific Title:Acronym A randomized multicenter trial of adjuvant IMF-001 after curative resection for esophageal cancer with NY-ESO-1 antigen (phase II study)
Region
Japan

Condition
Condition Patients after curative resection for esophageal cancer with NY-ESO-1 antigen expression
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To assess the disease-free survival and the safety of repeated doses of IMF-001.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Disease-free survival
Safety
Key secondary outcomes Overall survival

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 IMF-001-treated group:
IMF-001 0.2mg will be administered 6 times every 2 weeks, and 9 times every 4 weeks.
Interventions/Control_2 IMF-001-untreated group:
IMF-001 is not administered.
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 with esophageal squamous cell carcinoma, which is histologically or cytologically confirmed.
2) Tumor cells are judged expressing NY-ESO-1 antigen by immunohistochemistry.
3) Preoperative chemotherapy with regimen containing fluoropyrimidine and platinum.
4) Patients underwent esophagectomy with 2 or 3-field lymphadenectomy (R0-resection : UICC).
5) Clinical stage is either II or III or IV with supraclavicular lymph node metastasis (UICC Ver.7) .
6) Trial dosing is started within 12 weeks after resection.
7) Patients should be 20 years or older at enrollment.
8) No serious disorder of major organs (bone marrow, heart, lung, liver and kidney) and meet the following conditions ;
WBC count : >=2,000/mm3
Hemoglobin : >=8.0g/dL
Platelet count : >=75,000/mm3
Serum total bilirubin : <=1.5 x ULN
AST and ALT : <=2.5 x ULN
Serum creatinine : <=2 x ULN
9) Agree to use birth control including condom etc. from the time of obtaining the first consent to 6 months after the final administration of the study drug (except female after menopause (1 year or more after the last menstruation) and female/male after the operation for sterilization).
10) Given written informed consent.
Key exclusion criteria 1) Patients undergoing treatment with radiotherapy for esophageal cancer.
2) Patients with double cancer.
3) Patients with autoimmune disease.
4) HIV antibody positive.
5) History of serious anaphylaxis.
6) Within 4 weeks after treatment with immune suppressant, immune enhancer or systemically administered adrenocorticosteroid.
7) Pregnant or breast-feeding females and females who have a possibility of pregnancy.
8) Patients who are administered the other investigational product within 12 weeks of the secondary entry.
9) Any other inadequacy for this study.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Kageyama, M.D., Ph.D.
Organization Mie University Graduate School of Medicine
Division name Department of Immuno-gene Therapy
Zip code
Address 2-174, Edobashi, Tsu-city, Mie 514-8507 Japan
TEL 059-231-5397
Email kageyama@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Miyamoto
Organization Secretariat of clinical trial coordinating committee
Division name (none)
Zip code
Address Chiyoda-BLDG east, 2-9-4, Higashitenma, Kita-ku, Osaka 530-0044 Japan
TEL 06-6358-7110
Homepage URL
Email imf001_sec@fiverings.co.jp

Sponsor
Institute Department of Immuno-gene Therapy, Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 05 Month 14 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 Completed
Date of protocol fixation
2012 Year 02 Month 09 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2017 Year 10 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 07 Day
Date trial data considered complete
2017 Year 12 Month 07 Day
Date analysis concluded
2017 Year 12 Month 25 Day

Other
Other related information

Management information
Registered date
2012 Year 05 Month 08 Day
Last modified on
2018 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009311

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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