UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026187
Receipt number R000029971
Scientific Title Exploratory trial of a combination therapy of Gemcitabine and immunotherapy against pancreatic cancer.
Date of disclosure of the study information 2017/02/20
Last modified on 2018/02/19 09:06:57

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Basic information

Public title

Exploratory trial of a combination therapy of Gemcitabine and immunotherapy against pancreatic cancer.

Acronym

Exploratory trial of a combination therapy of Gemcitabine and immunotherapy against pancreatic cancer.

Scientific Title

Exploratory trial of a combination therapy of Gemcitabine and immunotherapy against pancreatic cancer.

Scientific Title:Acronym

Exploratory trial of a combination therapy of Gemcitabine and immunotherapy against pancreatic cancer.

Region

Japan


Condition

Condition

pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of the study is to examine the safety of a WT1-W10 immunotherapy combined with the standard, modified Gemcitabine chemotherapy. The auxiliary aim is to observe clinical responses and analyze immunological responses.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Adverse events of grade 3 or higher by the CTCAE criteria, Frequency of incidences at respective grade

Key secondary outcomes

Frequency of WT1 W10-specific CD8 T cells, DTH (delayed-type hypersensitivity at injection sites), measurement of the tumor size, immunohistochemistry of the tumor (if tumor tissue is obtained)


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

Medicine Vaccine

Interventions/Control_1

A combined chemoimmunotherapy of Gemcitabine plus WT1-W10 peptide vaccine

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) pancreatic cancer patients diagnosed by pathological examination
2) patients who have been informed about the disease
3) patients who are treated with chemotherapy using Gemcitabine as a single agent
4) The overexpression of WT1 in the tumor has been observed by immunohistochemical staining.
5) patients bearing one or two of HLA-A*24:02, A*02:01, A*02:06, or A*02:07 genes
6) 20 years of age or older, but less than 80 years
7) The performance status should be between 0-2 by the ECOG criteria
8) Function of major organs have been maintained.
Results of the clinical tests are within the following limits.
Neutrophil >= 1,000/ul
Platelets >= 40,000ul
Hemoglobin(Hb) >= 8g /dL
Serum bilirubin =< x3 of upper limit of normal(ULN)
AST and ALT =< x3 of ULN
Serum albumin >= 2.5g/dL
Serum creatinin =< 1.5mg/dL
ECG: no serious irregularities
Sp02 >= 94% (while breathing ambient air)
9) life expectancy > 4 months
10) Patient from whom a written consent is obtained.

Key exclusion criteria

1) Patients with uncontrollable infectious diseases (including active Tuberculosis)
2) patients with severe complications (malignant lypertension, severe congestive heart failure, severe colonary in sufficiency, myocardial, infarction within three months, terminal, stage of liver cirrhousis, uncontrollable diabetes mellitus, severe pulmonary fibrosis, active interstitial pneumonitis, etc.)
3) patients with serious comorbidities (generally those of NCI-CTC ver 3.0 grade 3 or higher)
4) patients who have been under parenteral nutrition for more than 24 hours due to impairment of digestive organs.
5) liver metastasis occupying more than 1/3 of the liver
6) Patients with active concomitant malignancy
7) patients with hematopoietic malignancies including MDS, MDS/MPD, CML
8) patients who have received bone marrow or hematopoietic stem cell transplantation
9) pregnant women, breast feeding mothers
10) patients with serious psychological disorders
11) patients whose participation to the study is considered inappropriate by the doctors for various reasons.

Target sample size

6


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiji Saibara

Organization

Kochi University, School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

Kohasu, Okocho, Nankoku, Kochi, 783-8505, Japan

TEL

088-866-5811

Email

vaccine@kochi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Keiko Udaka

Organization

School of Medicine, Kochi University

Division name

Anti-tumor Immunotherapy Research Network, Central Office, Department of Immunology

Zip code


Address

Kohasu, Okocho, Nankoku, Kochi, 783-8505, Japan

TEL

088-880-2318

Homepage URL


Email

vaccine@kochi-u.ac.jp


Sponsor or person

Institute

Department of Gastroenterology and Hepatology, Shool of Medicine, Kochi University

Institute

Department

Personal name



Funding Source

Organization

NEC Dorporation

Organization

Division

Category of Funding Organization

Profit 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



Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 20 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 10 Month 16 Day

Date of IRB


Anticipated trial start date

2012 Year 10 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

2017 Year 02 Month 17 Day

Last modified on

2018 Year 02 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029971


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name