UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003511
Receipt number R000004255
Scientific Title Clinical trial of hTERT-derived peptide vaccine for hepatocellular carcinoma
Date of disclosure of the study information 2010/04/26
Last modified on 2012/10/31 13:23:43

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Basic information

Public title

Clinical trial of hTERT-derived peptide vaccine for hepatocellular carcinoma

Acronym

A hTERT peptide vaccine for hepatocellular carcinoma

Scientific Title

Clinical trial of hTERT-derived peptide vaccine for hepatocellular carcinoma

Scientific Title:Acronym

A hTERT peptide vaccine for hepatocellular carcinoma

Region

Japan


Condition

Condition

Hepatocellular carcinoma (HCC)

Classification by specialty

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

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate safety and efficacy of hTERT peptide vaccine in HCC patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Evaluation of adverse events and immune responses

Key secondary outcomes

Evaluation of recurrence rate and tumor marker


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

Vaccine

Interventions/Control_1

Three times injection of hTERT-derived peptide 4 weeks after HCC local treatments every 2 weeks

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

1)HCC must be diagnosed
2)Karnofsky Performance Status is equal to or more than 70%
3)Patients must be equal to or more than 20 years old and written informed consent must be obtained
4)WBC is equal to or more than 2,000/mm3
5)Platelet is equal to or more than 50,000/mm3
6)Hb is equal to or more than 8.5 g/dl
7)Level of liver damage must be A or B
8)Serum Cr is equal to or less than 1.5 mg/dl

Key exclusion criteria

1)Severe complications associated with heart, kidney, lung, blood and coagulability
2)Infection of HIV
3)Past medical history of malignancy
4)Surgical treatment, chemotherapy and radiation therrapy within 4 weeks
5)Past medical history of Immunodeficiency, splenectomy and radiation of spleen
6)medical treatments with steroid or anti-histamine
7)Patients who are during lactation
8)Patients who are during pregnancy and expected pregnancy
9)Past history of organ transplantation
10)Patients who are predicted a difficulty of following clinical course
11)Patients who are judged inappropriate for clinical trial

Target sample size

14


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shuichi Kaneko

Organization

Kanazawa University Hospital

Division name

Gastroenterology

Zip code


Address

13-1 Takara-machi, Kanazawa city, Ishikawa

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Eishiro Mizukoshi

Organization

Kanazawa University Hospital

Division name

Gastroenterology

Zip code


Address

13-1 Takara-machi, Kanazawa city, Ishikawa

TEL

076-265-2235

Homepage URL


Email



Sponsor or person

Institute

Department of Gastroenterology, Kanazawa University Hospital

Institute

Department

Personal name



Funding Source

Organization

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

Organization

Division

Category of Funding 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

2010 Year 04 Month 26 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

2009 Year 10 Month 28 Day

Date of IRB


Anticipated trial start date

2009 Year 11 Month 01 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

2010 Year 04 Month 20 Day

Last modified on

2012 Year 10 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004255


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name