UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014099
Receipt number R000016412
Scientific Title The evaluation for safety and efficacy of combination therapy of adoptive immune-cell therapy with chemoradiotherapy for locally advanced esophageal cancer
Date of disclosure of the study information 2014/05/28
Last modified on 2015/01/08 21:09:59

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Basic information

Public title

The evaluation for safety and efficacy of combination therapy of adoptive immune-cell therapy with chemoradiotherapy for locally advanced esophageal cancer

Acronym

The evaluation for safety and efficacy of combination therapy of adoptive immune-cell therapy with chemoradiotherapy for locally advanced esophageal cancer

Scientific Title

The evaluation for safety and efficacy of combination therapy of adoptive immune-cell therapy with chemoradiotherapy for locally advanced esophageal cancer

Scientific Title:Acronym

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 (HLA type A2/A24)

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
inmature 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 with HLA A2 and/or A24
(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) Patients who are inadequate to enter this study due to the other reasons by physician's judgments

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Nakano

Organization

Gunma University

Division name

Department of Radiation Oncology, Gunma University Graduate School of Medicine

Zip code


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

1st name
Middle name
Last name Shin-ei Noda

Organization

Gunma University

Division name

Department of Radiation Oncology, Gunma University Graduate School of Medicine

Zip code


Address

3-39-22 Showa-machi, Maebashi, Gunma 371-8511, JAPAN

TEL

027-220-8383

Homepage URL


Email

snoda@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University

Institute

Department

Personal name



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)



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

群馬大学(群馬県)


Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 28 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

Open public recruiting

Date of protocol fixation

2013 Year 10 Month 10 Day

Date of IRB


Anticipated trial start date

2014 Year 05 Month 16 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 05 Month 28 Day

Last modified on

2015 Year 01 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016412


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name