UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study on safety and efficacy of System-i as new indwelling catheter system for hepatic arterial chemotherapy.
Title of the study (Brief title)	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	Seishi Nakatsuka
Organization	Department of Radiology, Keio University, school of medicine
Division name	Department of Radiology
Address	Shinanomachi 35, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	nakatsuk@a2.keio.jp

Public contact
Name of contact person	Yuuta Abe
Organization	Department of surgery, Keio University, school of medicine
Division name	Department of Surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 08 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019581