UMIN-CTR Clinical Trial

Public title

Phase II clinical trial of peptide vaccination with HLA-A2402-restricted KIF20A and VEGFR1 epitope peptides with gemcitabine chemotherapy in patients with unresectable advanced pancreatic cancer

Acronym

Phase II clinical trial of peptide vaccination with chemotherapy in patients with unresectable advanced pancreatic cancer

Scientific Title

Phase II clinical trial of peptide vaccination with HLA-A2402-restricted KIF20A and VEGFR1 epitope peptides with gemcitabine chemotherapy in patients with unresectable advanced pancreatic cancer

Scientific Title:Acronym

Phase II clinical trial of peptide vaccination with chemotherapy in patients with unresectable advanced pancreatic cancer

Region

Japan

Condition

pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of this study is to investigate clinical efficacy with Gemicitabine plus peptide vaccine therapy in patients with unresectable advanced pancreatic cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

overall survival

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Vaccine

Interventions/Control_1

Gemcitabine is administered at a dose of 1000 mg/m2 on days 1, 8, and 15 in a 28-day cycle. KIF20A and VEGFR1 peptides are subcutaneously injected weekly at each doses of 2 mg/body in patients with HLA-A*2402-positive group.

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

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Patients who have unresectable advanced pancreatic cancer before undergoing chemotherapy or vaccination.
2. Performance status (ECOG) of the patients are 0-2.
3. more than 20, less than 80 years of age.
4. The presence or absence of measurable or evaluable lesions by RECIST was not taken into account.
5. Patients who have undergone operation, and recovered the influence by surgery. Or two weeks or more have passed since pre-medical treatment.
6. Patients who can expect the survival of three months or more.
7. WBC count more than 3500/mm3, less than 10000/mm3. Plt count more than 100000/mm3. AST and ALT less than 150IU/L. T-Bil less than 2.0mg/dl. Creatinine less than 1.5mg/dl.
8. All patients gave written informed consent.

Key exclusion criteria

1. Patients have uncontrollable associated cancer.
2. Patients have uncontrollable severe infectional diseases.
3. Patients have severe trauma.
4. Patients who are treated with steroid or immunotherapy during clinical trial.
5. Pregnancy or lactation.
6. Patients who have non-recovered injury.
7. Patients judged inappropriated by doctors.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Sumio Watanabe

Organization

Juntendo University School of Medicine

Division name

Department of Gastroenterology

Zip code

Address

2-1-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email

sumio@juntendo.ac.jp

Name of contact person

1st name
Middle name
Last name	Junko Kato

Organization

Juntendo University School of Medicine

Division name

Department of Gastroenterology

Zip code

Address

2-1-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL

Email

jun-kato@juntendo.ac.jp

Institute

Department of Gastroenterology Juntendo University School of Medicine

Institute

Department

Personal name

Organization

Juntendo University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2010

Year

04

Month

20

Day

Date of IRB

Anticipated trial start date

2010

Year

05

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

12

Month

01

Day

Last modified on

2015

Year

06

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005536