UMIN-CTR Clinical Trial

Basic information
Public title	Combination of chemotherapy with docetaxel / cisplatin / fluorouracil (DCF) and autologous gamma/delta T cell transfer therapy for esophageal cancer.
Acronym	DCF and gamma/delta T cell therapy for esophageal cancer.
Scientific Title	Combination of chemotherapy with docetaxel / cisplatin / fluorouracil (DCF) and autologous gamma/delta T cell transfer therapy for esophageal cancer.
Scientific Title:Acronym	DCF and gamma/delta T cell therapy for esophageal cancer.
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the safety of the combination treatment and in vivo dynamics of gamma/delta T cells when DCF and gamma/delta T cells are given together in patients with recurrent or advanced esophageal cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Safety
Key secondary outcomes	Efficacy - Progression-free survival - Overall survival - Response rate - Survival rate (1 and 2 years) - Response of tumor-related markers - Immunological responses

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	-Docetaxel 60mg/m2 on day1 of each cycle -Cisplatin 60mg/m2 on day1 of each cycle -Fluorouracil 600mg/m2/day continuous infusion on days 1 through 5 each cycle -Autologous gamma/delta T cells on day15, day22. If after 2 cycles the patients cancer have not responded sufficiently they will be removed from the study. If significant reduction in the size of the tumor is observed after cycle 2. Treatment can be continued until response is assessed as PD.
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	Recurrent or unresectable advanced esophageal cancer patients who are eligible for DCF chemotherapy and meet the following: - Pathological Diagnosed of esophageal cancer; - Diagnosis of recurrent esophageal cancer by imaging; - Life-expectancy is more than 3 months; - Performance status is 0-1; - No serious abnormality in heart, lung, bone marrow, liver, and renal functions.
Key exclusion criteria	Patients who have: - Pulmonary fibrosis or interstitial pneumonia, including their history or predisposition; - Treated with chemoradiotherapy; - Active enteritis; - Active autoimmune diseases, - Active infections; - Other cancers; - Other serious complications; - Continuous systemic administration of steroids.
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Yasuyuki Seto
Organization	The University of Tokyo Hospital
Division name	Department of Gastrointestinal Surgery
Zip code
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL	03-3815-5411
Email	seto-tky@umin.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Kazuhiro Kakimi
Organization	The University of Tokyo Hospital
Division name	Department of Immunotherapeutics
Zip code
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL	03-5805-3161
Homepage URL
Email	immunotherapy-admin@umin.ac.jp

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

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

Other related organizations
Co-sponsor
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	東京大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 04 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	2012 Year 05 Month 30 Day
Date of IRB	2012 Year 05 Month 30 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 06 Month 04 Day
Last modified on	2019 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009529