UMIN-CTR Clinical Trial

Public title

Cancer Vaccine Therapy using Gene of antigen related to new cancer origin Epitope Peptide Restricted to HLA-A24 in Patients with Hepatocellular carcinoma(Phase 1/2 study).

Acronym

Cancer Vaccine Therapy using Epitope Peptide Restricted to HLA-A24 in Patients with Hepatocellular carcinoma(Phase1/2 study).

Scientific Title

Cancer Vaccine Therapy using Gene of antigen related to new cancer origin Epitope Peptide Restricted to HLA-A24 in Patients with Hepatocellular carcinoma(Phase 1/2 study).

Scientific Title:Acronym

Cancer Vaccine Therapy using Epitope Peptide Restricted to HLA-A24 in Patients with Hepatocellular carcinoma(Phase1/2 study).

Region

Japan

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine	Hepato-biliary-pancreatic surgery	Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of this study is to investigate safety and specific immuine responses on cancer vaccination therapy using multi peptides in patient with refractory hepatocellular carcinoma to Standard Therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase I,II

Primary outcomes

Evaluation of safety and specific immune response

Key secondary outcomes

Progression Free Survival(PFS)
Overall survival(OS)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Vaccine

Interventions/Control_1

peptide vaccination

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.It is diagnosed as the hepatocellular carcinoma by the case history and the diagnostic imaging. There is no adjustment of The operation, the radio wave cauterizing treatment, the transcatheter arterial embolization therapy,chemotherapy,radiotherapy,and the molecular-targeted therapy .
2.Performance status 0or1
3.The age when registering is from 20 or more to 80 years old or less.
4.There must be change to a morbid lesion that can be the measurement by RECIST.
5.Four weeks or more must pass from the prior treatment.
6.The vital prognosis should be able to be expected for three months or more.
7.WBC >= 1,500 and <=15,000,Platelet >=50,000/mm3 ,Child-PughAorB,Three times or less of keeping kidney function creatinine standard value.
8.Possess HLA-A*2402.
9.Understand the content of treatment, and obtain the person in question's agreement with the document.

Key exclusion criteria

1.The patient who has gullet or gastric varix, with the past of hemorrhage.The one of red color sign (RC2 or more) positivity regardless of the varicosity or F factor of F2 or more. (gullet and stomach varicosity endoscope guideline)
2.The one with pregnant woman, breast-feeding woman, and likelihood of pregnancy and the one in which pregnancy is hoped
3.It has a difficult briskness infectious disease to control.
4.The one with necessity for administering the following medicines while examining it. Whole body administration of adrenal steroid medicine and immunosuppressive agent's whole body administration (As for NSAIDS use is admitted).
5.After the liver transplant
6.It was admitted that the doctor was not suitable.
7.The one to hope for medical treatment to present disease such as Chemotherapy and Molecular-targeted therapy

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Kiyotaka Okuno

Organization

Kinki University School of Medicine

Division name

Department of Surgery

Zip code

Address

377-2 Ohnohigashi, Osakasayama, Osaka 589-8511, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Yasuyuki Nakata

Organization

Kinki University School of Medicine

Division name

Department of Surgery

Zip code

Address

377-2 Ohnohigashi, Osakasayama, Osaka 589-8511, Japan

TEL

Homepage URL

Email

Institute

Kinki University School of Medicine
Department of Surgery

Institute

Department

Personal name

Organization

Kinki University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Human Genome Center, Institute of Medical Science, The University of Tokyo

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

近畿大学医学部付属病院（大阪府）

Date of disclosure of the study information

2010

Year

12

Month

10

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

Enrolling by invitation

Date of protocol fixation

2010

Year

11

Month

11

Day

Date of IRB

Anticipated trial start date

2010

Year

12

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

03

Day

Last modified on

2011

Year

07

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005553