UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002837 |
|---|---|
| Receipt number | 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 10:14:30 |
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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
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
immunotherapy-admin@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003466
