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
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
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
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
