UMIN-CTR Clinical Trial

Public title

Phase I study of peptide-cocktail vaccination for HCV-positive patients with liver cancer who have undergone radical therapy.

Acronym

Peptid vaccination to prevent recurrence of HCV-positive liver cancer.

Scientific Title

Phase I study of peptide-cocktail vaccination for HCV-positive patients with liver cancer who have undergone radical therapy.

Scientific Title:Acronym

Peptid vaccination to prevent recurrence of HCV-positive liver cancer.

Region

Japan

Condition

liver cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The Object of the study is to investigate safety of peptide-cocktail vaccines consist of 10 cancer-derived peptides and 3 HCV-derived peptides emulsified with incomplete Freund's adjuvant.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

Safety, to evaluate with CTCAE v4.0

Key secondary outcomes

Immunological responses (anti-peptide IgG)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Vaccine

Interventions/Control_1

<Treatment with 6 times, every weeks>
Interview : Day1, 8, 15, 22, 29, 36
Treatment : Day1, 8, 15, 22, 29, 36
Watching adverse events : Day1, 8, 15, 22, 29, 36
Immune function test : Day36
Blood test : Day36

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

The subjects must satisfy the following conditions.
1)HCV-positive patients with liver cancer who have undergone radical therapy and no legion has been confirmed by ultrasonography and/or CT.
2) Patients must be at a score level
0~1 of performance status (PS) (ECOG).
3) Patients must satisfy the followings:
WBC is more than 2,200/mm3
Lymphocyte is more than 1,000/mm3
Hb is more than 8.0g/dL
Platelet is more than 50,000/mm3
Serum Creatinine is less than 2.0mg/dL
Total Bilirubin is less than 2.5mg/dL
4) Patients must be at a total score level 7 or less of Child-Pugh
5) Patients must be more 20 year-old or more to 80 years old or less.
6)Patients must be expected to survive more than 3 months.
7) Written informed consent must be obtained from patients.

Key exclusion criteria

The following patients must be excluded:
1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation).
2)Patients with multiple active cancers
3)Patients suspected with immunodeficiency and opportunistic infection.
4) Patients with the past history of severe allergic reactions.
5)Patients who are during pregnancy, lactation expectant, and desiring future fertility.
6)Patients with a score II or more of hepatic encephalopathy.
7) Patients who are judged inappropriate for the clinical trial by doctors.

Target sample size

3

Name of lead principal investigator

1st name
Middle name
Last name	Shigeru Yutani

Organization

Kurume University

Division name

Cancer Vaccine Center

Zip code

Address

Kokubu-machi 155-1, Kurume, Fukuoka 839-0863

TEL

0942-27-5210

Email

yutani@med.kurume-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Akira Yamada

Organization

Kurume University

Division name

Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division

Zip code

Address

Asahi-machi 67, Kurume, Fukuoka 830-0011, Japan

TEL

0942-31-7572

Homepage URL

Email

akiymd@med.kurume-u.ac.jp

Institute

Kurume University Cancer Vaccine Center

Institute

Department

Personal name

Organization

The Ministry of Education, Culture, Sports, Science, and Technology, Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

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

06

Month

21

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

05

Month

20

Day

Date of IRB

Anticipated trial start date

2010

Year

06

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

06

Month

17

Day

Last modified on

2014

Year

07

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004571