UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The evaluation for safety and efficacy of combination therapy of adoptive immune-cell therapy with chemoradiotherapy for locally advanced esophageal cancer
Title of the study (Brief title)	The evaluation for safety and efficacy of combination therapy of adoptive immune-cell therapy with chemoradiotherapy for locally advanced esophageal cancer
Region	Japan

Condition
Condition	Locally advanced esophageal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy about immune-cell therapy conducted concurrently with chemoradiotherapy for locally advanced esophageal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Safety Local control rate at one year
Key secondary outcomes	overall survival period overall survival rate Distant metastasis-free survival rete 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 Fluorouracil(5-FU) Cisplatin(CDDP) Alpha-Beta T-cell Therapy immature Dendritic cells 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 esophageal cancer (T2-3N0-1M0-1a, StageII-IVA except T4; UICC) (2) Patients can be conducted apheresis before chemotherapy (3) Patient age of 20 to 80 years (4) Patient with performance status 0-2 (5) Patient has more than three months of expected life time (6) Patients with no bone-marrow, liver, and renal dysfunction (7) Patient agrees to participate in this study with informed consent
Key exclusion criteria	(1) Patient with interstitial pneumonia (2) Patient who received cancer immunotherapy (3) Patient with active autoimmune disease (4) Patient with active heart disease (5) Patient with uncontrollable infectious diseases (6) Patient with serious drug allergy (7) Patient with uncontrollable diabetes mellitus (8) Patient with active multiple malignancies (9) Patient with continuous use of systemic administration of steroids (10) Patient with severe psychological disorders (11) Patient in pregnancy (12) Patient positive for HIV or HTLV-1 (13) Current participation in other drug clinical trials. (excluding the study, which doesn't need intervention) (14) Patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size	6

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	tnakano@gunma-u.ac.jp

Public contact
Name of contact person	Shin-ei Noda
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	snoda@gunma-u.ac.jp

Sponsor
Institute	Gunma University
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2015 Year 04 Month 30 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 11 Month 01 Day
Anticipated trial start date	2014 Year 11 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	2015 Year 04 Month 30 Day
Last modified on	2017 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020134