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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016887
Receipt No. 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

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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
Email 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
Email abey3666@gmail.com

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019581

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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