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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027770
Receipt No. 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 2019/06/17

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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
Institute Okayama University Hospital
Institute
Department

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 Enrolling by invitation
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
2020 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
2019 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.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


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