UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016887 |
|---|---|
| Receipt number | R000019581 |
| Scientific Title | A clinical study on safety and efficacy of System-i as new indwelling catheter system for hepatic arterial chemotherapy. |
| Date of disclosure of the study information | 2015/03/24 |
| Last modified on | 2018/10/04 19:58:21 |
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Basic information
Public title
A clinical study on safety and efficacy of System-i as new indwelling catheter system for hepatic arterial chemotherapy.
Acronym
A clinical study on safety and efficacy of System-i for hepatic arterial chemotherapy.
Scientific Title
A clinical study on safety and efficacy of System-i as new indwelling catheter system for hepatic arterial chemotherapy.
Scientific Title:Acronym
A clinical study on safety and efficacy of System-i for hepatic arterial chemotherapy.
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyze the safety and efficacy of System-i as therapeutic approach for advanced hepatocellular carcinoma.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Success rate of therapy (TACE or TAI) and safety
Key secondary outcomes
Implantation time of system
response rate
complication (liver dysfunction, stenosis of catheter)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The new indwelling catheter system (System-i) is embedded and TACE or TAI is performed from it.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histology/cytology-or clinically (by imaging or tumor marker) proven advanced hepatocellular carcinoma
2) ECOG performance status 0 or 1.
3) 20 years of age or older.
4) Liver function is preserved.
5) The function of the major organ is kept as satisfied by the following requirement,
a) WBC (Neutrophil) >= 3,000 (1,500)/microL
b)
d) Cr<=2.0 *Upper limit of Normal(ULN)
6) Obtained written consent from the patient before study.
Key exclusion criteria
1) ECOG performance status 3.
2) Uncontrollable extra-hepatic metastasis.
3) Symptomatic or under medication cardiac disease.
4) Having other cancer.
5) Having severe dysfunction (HCC rapture, uncontrolled diabetes, heart failure, MI, Arrhythmia, etc).
6) Having possibility of pregnant or nursing.
7) Deemed inappropriate to perform the study by the physician.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seishi Nakatsuka |
Organization
Department of Radiology, Keio University, school of medicine
Division name
Department of Radiology
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
03-3353-1211
nakatsuk@a2.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuuta Abe |
Organization
Department of surgery, Keio University, school of medicine
Division name
Department of Surgery
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
abey3666@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2015 | Year | 03 | Month | 24 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 24 | Day |
Last modified on
| 2018 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019581
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
