UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy and safety of combination therapy of adoptive immunotherapy with chemotherapy for advanced pancreatic cancer
Title of the study (Brief title)	Combination therapy of immunotherapy with chemotherapy for pancreatic cancer
Region	Japan

Condition
Condition	unresectable advanced pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of combination therapy of adoptive immunotherapy with chemotherapy for unresectable advanced pancreatic cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Overall survival (OS)
Key secondary outcomes	Survival rate (one year), Progression free survival, Quality of life (QOL), Tumor marker, Immunorogic reaction, The kind and frequency of side effect

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	1. Pancreatic cancer diagnosed histologically 2. Age: more than 20 years old and 20 y 3. Patients treated with chemottherapy 4. Performance status: 0-2 5. Survival more than three months 6. Maintained bone marrow, liver function and renal function 7. Written informed consent
Key exclusion criteria	1. Interstitial pneumonia 2. Active autoimmune disease 3. Uncontroled infection 4. Severe drug allergy 5. Continued steroid therapy 6. Pregnancy 7. HIV or HTLV-1 positive
Target sample size	20

Research contact person
Name of lead principal investigator	Yoshiaki Kawaguchi
Organization	Tokai University School of Medicine
Division name	Gastroenterology
Address	143, Shimokasuya, Isehara
TEL	0463-93-1121
Email	y711kawa@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	Yoshiaki Kawaguchi
Organization	Tokai University School of Medicine
Division name	Gastroenterology
Address	143, Shimokasuya, Isehara
TEL	0463-93-1121
Homepage URL
Email	y711kawa@is.icc.u-tokai.ac.jp

Sponsor
Institute	Tokai University School of Medicine
Institute
Department

Funding Source
Organization	Tokai University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Seta clinic
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

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 11 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 06 Month 25 Day
Anticipated trial start date	2013 Year 07 Month 11 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	We evaluate the efficacy and safety of immunotherapy combined with chemotherapy for unresectable advanced pancreatic cancer.

Management information
Registered date	2013 Year 07 Month 11 Day
Last modified on	2018 Year 01 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013093