UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of transarterial infusion therapy using carboplatin for hepatocelluar carcinoma with macroscopic vascular invasion
Title of the study (Brief title)	Effect of transarterial infusion therapy using carboplatin for hepatocelluar carcinoma with macroscopic vascular invasion
Region	Japan

Condition
Condition	Hepatocelluar carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We clarify the effect of transarterial infusion therapy using carboplatin for hepatocelluar carcinoma with macroscopic vascular invasion
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Desease free survival
Key secondary outcomes	respons rate of transarterial infusion therapy using CAM(carboplatin, adoriamaicin, mitomycin C), Over all survival, safty

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Medicine
Interventions/Control_1	transarterial infusion therapy using carboplatin
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Resectable hepatocelluar carcinoma with macroscopic vascular invasion 2)Child-Pugh classification A 3)PS(ECOG) score:0-1 4)Documently informed consented
Key exclusion criteria	1)Case with Extrahepatic metastasis 2)Case with complication as below(excluded chronic hepatitis and chirrosis) (1)Uncontrollable Cardiac dysfunction (2)AMI onset within 6 months (3)Renal failure (4)Active infection(excluded viral hepatitis) (5)Active GI bleeding (6)Active double cancer (7)Hepatic coma and mentalillness 3)Pregnantwoman,nursewoman and possible pregnantwoman 4)Case that are not suitable and not listed above
Target sample size	40

Research contact person
Name of lead principal investigator	Atsushi Sugioka
Organization	Fujita Health University School of Medicine
Division name	Depertment of hepatobiriary and transplant surgery
Address	1-98 dengakugakubo kutukake-cho toyoake city
TEL	0562-93-9248
Email	yoshinao@fujita-hu.ac.jp

Public contact
Name of contact person	Yoshinao Tanahashi
Organization	Fujita Health University School of Medicine
Division name	Depertment of hepatobiriary and transplant surgery
Address	1-98 dengakugakubo kutukake-cho toyoake city
TEL	0562-93-9248
Homepage URL
Email	yoshinao@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University School of Medicine Depertment of hepatobiriary and transplant surgery
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Fujita Health University School of Medicine Depertment of hepatobiriary and transplant surgery
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	2014 Year 12 Month 24 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 08 Month 03 Day
Anticipated trial start date	2014 Year 12 Month 24 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	2014 Year 12 Month 24 Day
Last modified on	2016 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018630