UMIN-CTR Clinical Trial

Public title

A Phase II study of Glypican-3(GPC3) peptide vaccine as adjuvant treatment for Hepatocellular carcinoma(HCC) after Surgical resection or Radiofrequency ablation(RFA)

Acronym

A Phase II study of GPC3 peptide vaccine as adjuvant treatment in the prevention of recurrence of HCC

Scientific Title

A Phase II study of Glypican-3(GPC3) peptide vaccine as adjuvant treatment for Hepatocellular carcinoma(HCC) after Surgical resection or Radiofrequency ablation(RFA)

Scientific Title:Acronym

A Phase II study of GPC3 peptide vaccine as adjuvant treatment in the prevention of recurrence of HCC

Region

Japan

Condition

Hepatocellular carcinoma(HCC)

Classification by specialty

Hepato-biliary-pancreatic medicine

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safety of GPC3 peptide vaccine in the adjuvant treatment of HCC after potentially curative surgical resection or RFA

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

The one-year and two-year recurrence rate

Key secondary outcomes

Adverse effects of GPC3 vaccination.
GPC3-specific immune-responses to GPC3 vaccination.

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

Vaccine

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, 6 times, and every 2 months, 4 times, total 10 times in a year, until disease recurrence

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

1. Diagnosed as initial HCC
2. Subjects who undergone potentially curative surgical resection or RFA for treatment of HCC
3. 4 to 6 weeks from resection or RFA, to CT/MRI scan date. Confirmation of CR (absence of residual tumor after curative treatment), on the eligibility CT/MRI scan.
4. Age: 20-85 years old
5. ECOG performance status of 0-2
6. Child-Pugh A or B
7. Meet the following criteria for organ functions.
Serum bilirubin:less than 3.0 mg/dL
Serum AST/ALT:less than 200U/L
Serum creatinine:less than 1.5 mg/dL
8. Written informed consent has been obtained.
9. HLA-A24 or -A2 positive

Key exclusion criteria

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

Target sample size

40

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

Division of Cancer Immunotherapy,

Zip code

Address

6-5-1, Kashiwanoha, Kashiwa, Japan

TEL

04-7131-5490

Email

tnakatsu@east.ncc.go.jp

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

Division of Cancer Immunotherapy,

Zip code

Address

6-5-1, Kashiwanoha, Kashiwa, Japan

TEL

04-7131-5490

Homepage URL

Email

tnakatsu@east.ncc.go.jp

Institute

Division of 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

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

2009

Year

10

Month

11

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

2009

Year

07

Month

14

Day

Date of IRB

Anticipated trial start date

2009

Year

10

Month

01

Day

Last follow-up date

2014

Year

10

Month

10

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

10

Month

11

Day

Last modified on

2014

Year

10

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003190