UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005847
Receipt number R000006898
Scientific Title Sorafenib in TACE-refractory or TACE-failure advanced hepatocellular carcinoma : Safety and effectiveness
Date of disclosure of the study information 2011/08/01
Last modified on 2013/12/26 10:07:27

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Basic information

Public title

Sorafenib in TACE-refractory or TACE-failure advanced hepatocellular carcinoma
: Safety and effectiveness

Acronym

Sorafenib in TACE-refractory or TACE-failure advanced hepatocellular carcinoma
: Safety and effectiveness

Scientific Title

Sorafenib in TACE-refractory or TACE-failure advanced hepatocellular carcinoma
: Safety and effectiveness

Scientific Title:Acronym

Sorafenib in TACE-refractory or TACE-failure advanced hepatocellular carcinoma
: Safety and effectiveness

Region

Japan


Condition

Condition

hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

safety and effectiveness of sorafenib in TACE-refractory or TACE-failure advanced hepatocellular carcinoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

progression free survival

Key secondary outcomes

time to progression, time to treatment failure, overall survival, response rate, disease control rate, safety


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.TACE-refractory or TACE-failure advanced hepatocellular carcinoma
2.patients appropriate to use sorafenib
3.Child-Pugh score:A
ECOG PS:0-1
Hemoglobin >8.5 g/dL
Neutorophil >1500 /micro L
Platelet >75000 /micro L
total bilirubin <2 mg/dL
AST, ALT <5 times the upper limit of the normal range in local laboratories

Key exclusion criteria

1.Patients unsuitable for Sorafenib
Allergic reaction to Sorafenib, Pregnant women, Poor renal function(required hemodialysis), Past history of thromboembolism or ischemic heart disease
Poor control of hypertension
2.Severe vascular invasion(Vp3,4)

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Etsuro Hatano

Organization

Kyoto university hospital

Division name

surgery

Zip code


Address

54 Kawarachou shougoin sakyouku kyoto

TEL

075-751-3242

Email

etsu@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kohta Iguchi

Organization

Kyoto university hospital

Division name

surgery

Zip code


Address

54 Kawarachou shougoin sakyouku kyoto

TEL

075-751-3242

Homepage URL


Email

iguchik@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto university hospital

Institute

Department

Personal name



Funding Source

Organization

Trust accounts

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

2011 Year 08 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

Open public recruiting

Date of protocol fixation

2011 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Safety and efficacy of sorafenib


Management information

Registered date

2011 Year 06 Month 26 Day

Last modified on

2013 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006898


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name