UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027770
Receipt number R000031791
Scientific Title Phase I/Ib study of Ad-SGE-REIC-GH in patient with liver cancer.
Date of disclosure of the study information 2017/06/20
Last modified on 2023/06/28 17:44:16

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Basic information

Public title

Phase I/Ib study of Ad-SGE-REIC-GH in patient with liver cancer.

Acronym

Phase I study of Ad-SGE-REIC-GH in patient with liver cancer.

Scientific Title

Phase I/Ib study of Ad-SGE-REIC-GH in patient with liver cancer.

Scientific Title:Acronym

Phase I study of Ad-SGE-REIC-GH in patient with liver cancer.

Region

Japan


Condition

Condition

Liver cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate safety of Ad-SGE-REIC-GH in patient with liver cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I


Assessment

Primary outcomes

Assessment of safety

Key secondary outcomes

Objective Response Rate (ORR)
Disease Control Rate (DCR)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Gene

Interventions/Control_1

intra-tumor injection of Ad-SGE-REIC
three times with two weeks interval

level 1: 3.0x10^11 vp(viral particle)
level 2: 1.0x10^12 vp
level 3: 3.0x10^12 vp

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Histological confirmed hepatocellular carcinoma or liver metastasis of pancreatic cancer
Ability to understand and the willingness to sign a written informed consent document
Patients must have measurable disease.
Patient refractory to or intolerant of standard therapy
Life expectancy over 3 months
Neutrophil count >= 1000/uL
Hemoglobin >= 8.5g/dL
Platelets >= 60,000/uL
Albumin >= 2.8 g/dL
Total bilirubin =< 2x institutional upper limit of normal
AST =< 5x institutional upper limit of normal
ALT =< 5x institutional upper limit of normal
INR 0.8 - 2x institutional upper limit of normal
Creatinine =< 2 x institutional upper limit of normal
ECOG performance status of 0 or 1
Child-Pugh scale =< 7
Patient must agree to use adequate contraception

Key exclusion criteria

Patient with active bacterial, fungal or viral infections. Hepatitis B or C is allowed
Patient with brain metastasis
Patient with other malignancies
HIV-positive
Patient with angina pectoris, congestive heart failure, or myocardial infarction less than 1 year previously
Patient with psychiatric illness that would limit compliance with study requirements
Pregnant women, women suspect she is pregnant, or lactating woman
Patient have a history of allergic reactions against drugs used in this study
Any experimental anti-cancer drug therapy within 4weeks prior to this study
Any anti-cancer drug therapy within 4 weeks prior to this study
Patient received topical therapy within 4 weeks prior to this study
Patient on anticoagulation or antiplatelet therapy
Poor glycemic control measured as HbA1C >8.0
Patient is on chronic systemic steroid therapy

Target sample size

12


Research contact person

Name of lead principal investigator

1st name Hidenori
Middle name
Last name Shiraha

Organization

Okayama University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558

TEL

086-235-7220

Email

hshiraha@okayama-u.ac.jp


Public contact

Name of contact person

1st name Hidenori
Middle name
Last name Shiraha

Organization

Okayama University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558

TEL

086-235-7220

Homepage URL


Email

hshiraha@okayama-u.ac.jp


Sponsor or person

Institute

Okayama University Hospital

Institute

Department

Personal name



Funding Source

Organization

self-funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB

Address

2-5-1 Shikata-cho, Okayama 700-8558, Japan

Tel

086-235-7991

Email

chiken@okayama-u.ac.jp


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

2017 Year 06 Month 20 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

Open public recruiting

Date of protocol fixation

2017 Year 03 Month 31 Day

Date of IRB

2016 Year 09 Month 20 Day

Anticipated trial start date

2017 Year 06 Month 20 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 06 Month 15 Day

Last modified on

2023 Year 06 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031791


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name