UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007841
Receipt No. R000008752
Scientific Title Phase I study of immuno-Cell therapy for advanced and recurrent esophageal squamous cell carcinoma
Date of disclosure of the study information 2012/05/01
Last modified on 2013/05/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase I study of immuno-Cell therapy for advanced and recurrent esophageal squamous cell carcinoma
Acronym Phase I study of immuno-Cell therapy for advanced and recuerent esophageal squamous cell carcinoma
Scientific Title Phase I study of immuno-Cell therapy for advanced and recurrent esophageal squamous cell carcinoma
Scientific Title:Acronym Phase I study of immuno-Cell therapy for advanced and recuerent esophageal squamous cell carcinoma
Region
Japan

Condition
Condition Advanced and recurrent esophageal squamous cell carcinoma
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify the safety and adverse event of immuno-Cell therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety and responsibility
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Immunocell therapy using activated lymphocytes injections
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Life expectancy of more than 12 weeks
2.Performance status 0-2
3.Age from 20 to 80 years
4.Adequate organ function
WBC:>2,000/ mm3 <15,000/mm3
Hb:>7.0 g/dl
Plt:>75,000/mm3
AST(GOT),ALT(GPT):<150 IU/l
T-Bil:<2.0mg / dl
Cr: <2.0mg/dl
5.Written informed consent
Key exclusion criteria 1.patient who has severe complication
2.patient who has bleeding tendency
3.patient who has active infectious disease
4.concomitant treatment with steroids
5.HBs antigen, HCV antibody, HIV antibody or HTLV-1 antibody is positive
6.patient who has activated autoimmune disease
7.patient who was judged to be unsuitable for this clinical trial
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Shimada
Organization Toho University Omori Medical Center
Division name Department of Surgery
Zip code
Address 6-11-1 Omorinishi Ota-ku Tokyo Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Toho University School of Medicine
Division name Department of Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Toho University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 01 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
2011 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 26 Day
Last modified on
2013 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008752

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.