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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002837
Receipt No. R000003466
Scientific Title Safety, efficacy and immunogenicity of autologous tumor lysate-pulsed dendritic cell therapy after resection of stage2A (T2N0,T3N0) esophageal cancer
Date of disclosure of the study information 2009/12/03
Last modified on 2016/06/22

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Basic information
Public title Safety, efficacy and immunogenicity of autologous tumor lysate-pulsed dendritic cell therapy after resection of stage2A (T2N0,T3N0) esophageal cancer
Acronym Autologous tumor lysate-pulsed dendritic cell therapy after resection of esophageal cancer
Scientific Title Safety, efficacy and immunogenicity of autologous tumor lysate-pulsed dendritic cell therapy after resection of stage2A (T2N0,T3N0) esophageal cancer
Scientific Title:Acronym Autologous tumor lysate-pulsed dendritic cell therapy after resection of esophageal cancer
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate safety and efficacy of autologous tumor lysate-pulsed dendritic cell therapy after curative resection for esophageal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Safety
Key secondary outcomes Immunological responses
Recurrence rate
Recurrence-free survival
Overall survival
Survival rate
Response of tumor-related markers

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Vaccine Maneuver
Interventions/Control_1 Tumor lysate-pulsed dendritic cells are injected on day0, day14, day28, day42, day56, day70.
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 Esophageal cancer patients who received curative resection and are histopathologically diagnosed as T2N0 or T3N0:
-Performance status is 0-2;
-20 years or more;
-No serious abnormality in heart, lung, bone marrow, liver, and renal functions;
-Tumor tissue is preserved after resection and tumor lysate is aseptically prepared;
-MHC class1 expression on tumor tissue is detected by immunohistochemistry
Key exclusion criteria Patients who have:
-Pulmonary fibrosis or interstitial pneumonia, including their history or predisposition;
-Serious drug allergy;
-Difficult infections to control;
-Serious cardiac diseases;
-Active autoimmune diseases;
-Other cancers;
-Continuous systemic administration of steroids and/or immunosuppressants within 4 weeks.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyuki Seto
Organization The University of Tokyo Hospital
Division name Gastrointestinal Surgery Division
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-5800-9730
Email seto-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Kakimi
Organization The University of Tokyo, Graduate School of Medicine
Division name Department of Immunotherapeutics
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-5805-3161
Homepage URL
Email immunotherapy-admin@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization Medinet Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
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 東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 03 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
2009 Year 11 Month 09 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2016 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 12 Month 03 Day
Last modified on
2016 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003466

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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