UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety, efficacy and immunogenicity of autologous tumor lysate-pulsed dendritic cell therapy after resection of stage2A (T2N0,T3N0) esophageal cancer
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yasuyuki Seto
Organization	The University of Tokyo Hospital
Division name	Gastrointestinal Surgery Division
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	Kazuhiro Kakimi
Organization	The University of Tokyo, Graduate School of Medicine
Division name	Department of Immunotherapeutics
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 11 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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