UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000931
Receipt number R000001115
Scientific Title Clinical study to investigate safety and efficacy on combination of gemcitabine and autologous gamma/delta T cell transfer therapy after resection of pancreatic cancer
Date of disclosure of the study information 2007/12/05
Last modified on 2015/06/05 10:14:53

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Basic information

Public title

Clinical study to investigate safety and efficacy on combination of gemcitabine and autologous gamma/delta T cell transfer therapy after resection of pancreatic cancer

Acronym

Clinical study of gemcitabine and gamma/delta T cell therapy after resection of pancreatic cancer

Scientific Title

Clinical study to investigate safety and efficacy on combination of gemcitabine and autologous gamma/delta T cell transfer therapy after resection of pancreatic cancer

Scientific Title:Acronym

Clinical study of gemcitabine and gamma/delta T cell therapy after resection of pancreatic cancer

Region

Japan


Condition

Condition

Pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate safety and efficacy on combination of gemcitabine and autologous gamma/delta T cell transfer therapy after resection of pancreatic cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Safety

Key secondary outcomes

Relapse rate (1 and 2 years)
Relapse free survival
Overall survival
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

Interventions/Control_1

Gamma/delta T cells are injected on day0, day14, day28, day42, day56, day70, day84, day98, day112, day126, day140, day154.

Gemcitabine on day-3, day4, day11, day25, day32, day39, day53, day60, day67, day81, day88, day95, day109, day116, day123, day137, day144, day151.

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

Pancreatic cancer patients who have received curative resection:
- No macroscopically and pathologically
residual tumor (R0), or no
macroscopically residual tumor (R1);
- Life-expectancy is more than 3 months;
- Performance status is 0-1;
- No serious abnormality in bone marrow,
liver, and renal functions.

Key exclusion criteria

Patients who have:
- Pulmonary fibrosis or interstitial
pneumonia, or their history, or
predisposition to them;
- Active enteritis, autoimmune diseases,
and/or infections;
- Other cancers;
- Other serious complications;
- Continuous systemic administration of
steroids.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norihiro Kokudo

Organization

The University of Tokyo Hospital

Division name

Hepato-Biliary-Pancreatic Surgery Division

Zip code


Address

7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan

TEL

03-5800-8654

Email

KOKUDO-2SU@h.u-tokyo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuhiro Kakimi

Organization

The University of Tokyo, Graduate School of Medicine

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 or person

Institute

The University of Tokyo Hospital

Institute

Department

Personal name



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



Other administrative information

Date of disclosure of the study information

2007 Year 12 Month 05 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

2007 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2007 Year 12 Month 01 Day

Last follow-up date

2015 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

2007 Year 12 Month 05 Day

Last modified on

2015 Year 06 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001115


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name