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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014999
Receipt No. R000017427
Scientific Title Comparison of Sorafenib and DEB-TACE in patients wth hepatocellular carcinoma refractory to conventional TACE.
Date of disclosure of the study information 2014/09/01
Last modified on 2019/09/19

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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

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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