UMIN-CTR Clinical Trial

Public title

Clinical study for evaluating immunological efficacy of Glypican-3 peptide vaccine in patients with advanced Hepatocellular carcinoma

Acronym

Clinical study for evaluating immunological efficacy of GPC3 peptide vaccine in patients with HCC

Scientific Title

Clinical study for evaluating immunological efficacy of Glypican-3 peptide vaccine in patients with advanced Hepatocellular carcinoma

Scientific Title:Acronym

Clinical study for evaluating immunological efficacy of GPC3 peptide vaccine in patients with HCC

Region

Japan

Condition

Hepatocellular Carcinoma (HCC)

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We will investigate the GPC3 peptide-specific immune responses induced by GPC3-derived peptide vaccine in both peripheral blood and tumor.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

GPC3 peptide-specific immune-responses induced by GPC3 peptide vaccination.
1 Increase of frequency of GPC3-peptide specific CD8 positive T lymphocytes in the blood.
2 Increase of frequency of CD8 positive T lymphocytes into the tumor

Key secondary outcomes

Time to Progression : TTP
Disease Control Rate : DCR
Response Rate : RR
Rate of 50% decreasing the level of serum tumor marker
Rate of 50% decreasing the number of Circulating Tumor Cells(CTC)
Adverse effects of GPC3 vaccination.
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

Maneuver

Interventions/Control_1

Injection of HLA-A24- or -A2-restricted GPC3 peptide (EYILSLEEL or FVGEFFTDV) emulsified with Montanide ISA51 adjuvant.
3 mg intradermally injection, every 2 weeks.
Tumor tissue biopsies after 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

85

years-old

>

Gender

Male and Female

Key inclusion criteria

Advanced HCC patient satisfying the following conditions,
1 Diagnosed as HCC
2 Age: 20-85 years old
3 ECOG performance status of 0-1
4 Child-Pugh A or B
5 Meet the following criteria for organ functions.
1. Neutrophil: more than 1,500/mm3
2. Hemoglobin: more than 8.0g/dL
3. Platelet: more than 50,000/mm3
4. Serum bilirubin: less than 3.0 mg/dL
5. Serum albumin: less than 2.8 g/dL
6. Serum AST/ALT: less than 150U/L
7. Serum creatinine: less than 1.5 mg/dL
6 HLA-A*24:02 or HLA-A*02:01, 02:06, 02:07 positive
7 Tumor tissue biopsy is practicable
8 At least 2 weeks since last therapy for HCC.
9 Written informed consent has been obtained.

Key exclusion criteria

1. Uncontrolled pleural effusion or ascites
2. There are other malignancies
3. Active infection excluding HBV, HCV
4. Clinically significant heart disease (myocardial infarction or unstable angina within the past six months, or uncontrolled cardiac arrhythmias)
5. There are severe complications including cardiac failure, renal failure, liver failure, active gastro-duodenal ulcer, ileus, and uncontrolled Diabetes Mellitus
6. There is severe psychiatric disorder
7. Pregnant or lactating woman, who are willing to be pregnant
8. Past history of severe drug allergy
9. Past history of administration of GPC3 peptide vaccination
10. Responsible doctors judged the patient in appropriate for the trial

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Tetsuya Nakatsura

Organization

Research Center for Innovative Oncology, National Cancer Center Hospital East

Division name

Section for Cancer Immunotherapy,

Zip code

Address

6-5-1, Kashiwanoha, Kashiwa, Japan

TEL

04-7131-5490

Email

Name of contact person

1st name
Middle name
Last name	Tetsuya Nakatsura

Organization

Research Center for Innovative Oncology, National Cancer Center Hospital East

Division name

Section for Cancer Immunotherapy,

Zip code

Address

6-5-1, Kashiwanoha, Kashiwa, Japan

TEL

04-7131-5490

Homepage URL

Email

tnakatsu@east.ncc.go.jp

Institute

Section for Cancer Immunotherapy,
Investigative Treatment Division, Research Center for Innovative Oncology, National Cancer Center Hospital East

Institute

Department

Personal name

Organization

The Ministry of Health, Labor and Welfare, Japan

Organization

Division

Category of Funding Organization

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

国立がん研究センター東病院（千葉県）

Date of disclosure of the study information

2011

Year

02

Month

16

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

2011

Year

01

Month

26

Day

Date of IRB

Anticipated trial start date

2011

Year

02

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

2011

Year

02

Month

16

Day

Last modified on

2013

Year

05

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006053