UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of combination therapy of adoptive immune-cell therapy with chemoradiothrapy for pancreatic cancer
Title of the study (Brief title)	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	Takashi Nakano
Organization	Gunma University
Division name	Department of Radiation Oncology, Gunma University Graduate School of Medicine
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	Yoshiyuki Suzuki
Organization	Gunma University
Division name	Department of Radiation Oncology, Gunma University Graduate School of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000015674