UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of Sorafenib and DEB-TACE in patients wth hepatocellular carcinoma refractory to conventional TACE.
Acronym	The investigation for the therapy of hepatocellular carcinoma refractory to conventional TACE.
Scientific Title	Comparison of Sorafenib and DEB-TACE in patients wth hepatocellular carcinoma refractory to conventional TACE.
Scientific Title:Acronym	The investigation for the therapy of hepatocellular carcinoma refractory to conventional TACE.
Region	Japan

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

Objectives
Narrative objectives1	To clarify the best therapy for hepatocellular carcinoma refractory to conventional TACE.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	overall survival rate
Key secondary outcomes	progression-free survival response rate

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients with HCC. 2)Patients whose TMN stage of HCC is II, III or IVa. 3)Patiets that written agreement of participation for this study was obtained. 4)Patients with HCC refractory to conventional TACE. 5)Patients whose Child-Pugh is A.
Key exclusion criteria	1)Patiets that written agreement of participation for this study was not obtained. 2)Patients whose HCC with invasion of stem of portal vein. 3)Patients with uncontrollable ascites. 4)Patients whose TMN stage of HCC is IVb. 5)Patients whose Child-Pugh is B or C. 6)Pregnant patiients. 7)Patients with iodine hypersensitivity. 8)Patients who were estimated that study entry is inappropriate by the responsible physician.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name kouji Joko
Organization	Matsuyama Red Cross Hospital
Division name	Center for liver-Billiary-Pancreatic Diseases
Zip code
Address	1 Bunkyo-cho, Matsuyama, Ehime, Japan
TEL	089-924-1111
Email	koujijoko@matsuyama.jrc.or.jp

Public contact
Name of contact person	1st name Middle name Last name hironori Ochi
Organization	Matsuyama Red Cross Hospital
Division name	Center for liver-Billiary-Pancreatic Diseases
Zip code
Address	1 Bunkyo-cho, Matsuyama, Ehime, Japan
TEL	089-924-1111
Homepage URL
Email	hironori19810211@matsuyama.jrc.or.jp

Sponsor
Institute	Musashino Red Cross Hospital
Institute
Department

Funding Source
Organization	Health and Labor Sciences Research Grants for Research on Hepatitis from Ministry of Health, Labor and Welfare, Japan.
Organization
Division
Category of Funding Organization	Other
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	2014 Year 09 Month 01 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 25 Day
Date of IRB	2014 Year 09 Month 01 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date	2019 Year 09 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Comparison of Sorafenib and DEB-TACE in patients with hepatocellular carcinoma refractory to conventional TACE: The investigation by Jananese red cross liver study group.

Management information
Registered date	2014 Year 08 Month 30 Day
Last modified on	2019 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017427