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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013426
Receipt No. R000015674
Scientific Title Clinical study of combination therapy of adoptive immune-cell therapy with chemoradiothrapy for pancreatic cancer
Date of disclosure of the study information 2014/03/14
Last modified on 2017/03/17

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Basic information
Public title Clinical study of combination therapy of adoptive immune-cell therapy with chemoradiothrapy for pancreatic cancer
Acronym Clinical study of combination therapy of adoptive immune-cell therapy with chemoradiothrapy for pancreatic cancer
Scientific Title Clinical study of combination therapy of adoptive immune-cell therapy with chemoradiothrapy for pancreatic cancer
Scientific Title:Acronym Clinical study of combination therapy of adoptive immune-cell therapy with chemoradiothrapy for pancreatic cancer
Region
Japan

Condition
Condition pancreatic cancer (HLA type A2/A24)
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy about concurrent therapy of immune-cell therapy and chemoradiotherapy for pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes disease-free rate
Key secondary outcomes overall survival period
overall survival rate
Distant metastasis-free survival rete
Frequency and type of adverse events
QOL
immunological parameters

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
Medicine Maneuver
Interventions/Control_1 Radiation therapy
Gemcitabine
Alpha-Beta T-cell Therapy
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)Patient with locally advanced pancreatic cancer without prior treatment
(2)Patient who can be treated with adoptive immune-cell therapy and chemoradiotherapy
(3)Patient with HLA A2 and/or A24
(4)Patient age of 20 to 80 years
(5)Patient with performance status 0-2
(6)Patient has more than three months of expected life time
(7)Patient with no serious abnormality in bone marrow, liver, and renal functions
(8)Patient agrees to participate in this study with informed consent
Key exclusion criteria (1)Patient with interstitial pneumonia
(2)Patient with active autoimmune disease
(3)Patient with active heart disease
(4)Patient with uncontrolable infectious diseases
(5)Patient with serious drug allergy
(6)Patient with continuous use of systemic administration of steroids
(7)Patient in pregnancy
(8)Patient positive for HIV or HTLV-1
(9)patient who is inadequate to enter this study due to the other reasons by physician's judgments
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Nakano
Organization Gunma University
Division name Department of Radiation Oncology, Gunma University Graduate School of Medicine
Zip code
Address 3-39-22 Showa-machi, Maebashi, Gunma 371-8511, JAPAN
TEL 027-220-8383
Email syoshi@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Suzuki
Organization Gunma University
Division name Department of Radiation Oncology, Gunma University Graduate School of Medicine
Zip code
Address 3-39-22 Showa-machi, Maebashi, Gunma 371-8511, JAPAN
TEL 027-220-8383
Homepage URL
Email syoshi@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Medinet Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Seta Clinic Group
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 群馬大学(群馬県)

Other administrative information
Date of disclosure of the study information
2014 Year 03 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
2013 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date
2014 Year 04 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
2014 Year 03 Month 14 Day
Last modified on
2017 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015674

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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