UMIN-CTR Clinical Trial

Basic information
Public title	Safety and Efficacy Study of Sorafenib in Japanese Child-Pugh A and B Patients with Advanced Hepatocellular Carcinoma
Acronym	Safety and Efficacy Study of Sorafenib in Japanese patients with Advanced Hepatocellular Carcinoma
Scientific Title	Safety and Efficacy Study of Sorafenib in Japanese Child-Pugh A and B Patients with Advanced Hepatocellular Carcinoma
Scientific Title:Acronym	Safety and Efficacy Study of Sorafenib in Japanese patients with Advanced Hepatocellular Carcinoma
Region	Japan

Condition
Condition	Advanced Hepatcellular Carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of Sorafenib for Japanese Child-Pugh A and B patients with advanced hepatocellular carcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Time to Progression (TTP)
Key secondary outcomes

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	Sorafenib 400mg twice daily
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)Age >= 20 years 2)Patients who have been diagnosed with hepatocellular carcinoma by histologycally or typical diagnostic images 3)No indication for surgical resection, local thrapy(Percutaneous ethanol injection, radiofrequency ablation, microwave coagulation therapy, transcatheter arterial chemoembolization, radiation therapy) 4)Child-Pugh A or B 5)Performance status (ECOG scale): 0,1 or 2 6)Life expectancy of at least 12 weeks 7)At least 1 target lesion measurable 8)Adequate organ function
Key exclusion criteria	1)Second primary malignancy 2)Severe cardiac complication 3)Active infection 4)HIV infection 5)Encephalopacy 6)Gastro-esophazeal varices requiring preventive treatment 7)Uncontrolled massive ascitis
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Osamu Yokosuka
Organization	Chiba University Hospital
Division name	Department of Gastroenterology
Zip code
Address	1-8-1 Inohana, Chuou-ku, Chiba
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Sadahisa Ogasawara
Organization	Chiba University Hospital
Division name	Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email	ogasawaras@graduate.chiba-u.jp

Sponsor
Institute	Chiba University Hospital
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)

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	2010 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

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	Completed
Date of protocol fixation	2010 Year 04 Month 19 Day
Date of IRB
Anticipated trial start date	2010 Year 05 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

Management information
Registered date	2010 Year 09 Month 15 Day
Last modified on	2016 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005065

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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