UMIN-CTR Clinical Trial

Basic information
Public title	Basic research of immunotherapy using dendritic cells derived from induced pluripotent stem cells in healthy donors and cancer patients
Acronym	Basic research of immunotherapy using dendritic cells derived from induced pluripotent stem cells in healthy donors and cancer patients
Scientific Title	Basic research of immunotherapy using dendritic cells derived from induced pluripotent stem cells in healthy donors and cancer patients
Scientific Title:Acronym	Basic research of immunotherapy using dendritic cells derived from induced pluripotent stem cells in healthy donors and cancer patients
Region	Japan

Condition
Condition	Advanced or recurrent gastrointestinal cancer
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To verify the capacity of dendritic cells (DCs) derived from iPS cells in healthy donors and cancer patients to prime tumor-associated antigen (TAA)-specific cytotoxic T cells (CTLs) in vitro
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To investigate the capacity of the DCs derived from iPS cells in healthy donors and cancer patients to prime TAA-specific CTLs comparatively with the DCs derived from peripheral blood mononuclear cells (PBMCs) in the donors and the patients
Key secondary outcomes	To investigate the morphology of the DCs derived from iPS cells in healthy donors and cancer patients comparatively with the DCs derived from PBMCs in the donors and the patients To investigate the capacity in terms of maturation and migration of the DCs derived from iPS cells in healthy donors and cancer patients comparatively with the DCs derived from PBMCs in the donors and the patients To verify the expression of tumor associated antigen in cancer cells sampled from cancer patients

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	Maneuver
Interventions/Control_1	Collection of blood sample up to 50ml Sampling cancer tissue from cancer patients within the necessary to treat the patients
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Advanced or recurrent gastrointestinal cancer confirmed adenocarcinoma or squamous cell carcinoma 2)Over clinical StageIII in UICC-TNM 3)Aged from 20 to 75 years 4)Performance status 0 or 1 5)Patient who has never had chemotherapy, radiation therapy, and endocrine therapy for cancer 6)Sufficient functions of major organ 7)Full filling the following conditions within 2 weeks before registration WBC from 4,000/mm3 to 12,000/mm3. Neutrophils over 2,000/mm3. Hemoglobin over 8.0g/dL. Plate over 100,000/mm3. AST under 100IU/L, or ALT under 100IU/L. Total bilirubin under 1.5mg/dL. Serum creatinine under 1.2mg/dL. Creatinine clearance over 60mL/min/body. 8)Having written informed consent
Key exclusion criteria	1)Active other malignancy, except lesions of "carcinoma in situ" or intramucosal location which are curatively resectable 2)Pregnant or lactating woman 3)Sever mental impairment 4)Active or uncontrolled clinically serious infection, except local infection not influencing general status 5)Judged inappropriate by the investigators
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Toshiyasu Middle name Last name Ojima
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	811-1 Kimiidera, Wakayama, Japan
TEL	073-441-0613
Email	tojima@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Hirotaka Middle name Last name Tabata
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	811-1 Kimiidera, Wakayama, Japan
TEL	073-441-0613
Homepage URL
Email	htabata@wakayama-med.ac.jp

Sponsor
Institute	Second Department of Surgery, Wakayama Medical University, School of Medicine
Institute
Department

Funding Source
Organization	Second Department of Surgery, Wakayama Medical University, School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Second Department of Surgery, Wakayama Medical University
Address	Kimiidera 811-1 Wakayama
Tel	0734410613
Email	tojima@wakayama-med.ac.jp

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	和歌山県立医科大学病院（和歌山県）

Other administrative information
Date of disclosure of the study information	2016 Year 03 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	Enrolling by invitation
Date of protocol fixation	2016 Year 02 Month 15 Day
Date of IRB	2016 Year 01 Month 31 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date	2021 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 19 Day
Last modified on	2020 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024348