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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002972
Receipt No. R000003606
Scientific Title Phase II study of sorafenib in patients with advanced hepatocellular carcinoma
Date of disclosure of the study information 2010/01/05
Last modified on 2019/01/15

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Basic information
Public title Phase II study of sorafenib in patients with advanced hepatocellular carcinoma
Acronym Phase II study of sorafenib in patients with advanced hepatocellular carcinoma
Scientific Title Phase II study of sorafenib in patients with advanced hepatocellular carcinoma
Scientific Title:Acronym Phase II study of sorafenib in patients with advanced hepatocellular carcinoma
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and toxicity of sorafenib for advanced hepatocellular carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Adverse events
Response rate
Overall survival

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 Sorefenib is administered orally until disease progression.
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
79 years-old >=
Gender Male and Female
Key inclusion criteria 1) hepatocellular carcinoma confirmed histologically or clinically (typical diagnostic images and over the upperlimit of AFP)
2) No indication for surgical resection, liver transplantation, local ablation therapy or transarterial chemoembolization
3) aged 20-79 years old
4) measurable or assessable lesion(s)
5) ECOG Performance Status 0-2
6) Adequate organ function
a) Neutrophil>=1000 /mm3
b) Hb>= 8.0 g/dL
c) PLT>= 50000 /mm3
d) T-Bil<= 3.0 mg/dL
e) Albumin>= 2.8 g/dL
f) AST<= 150 IU/L
g) ALT<= 150 IU/L
h) Amylase<= 300 U/L
i) Cre<= 1.5 mg/dl
7) Child-Pugh score 5-8 points
8) Interval of at least 4 weeks between last treatment and start of present chemotherapy regimen
9) No prior systemic chemotherapy
10) Written informed consent
11) Life expectancy of at least 8 weeks
Key exclusion criteria 1)Massive pleural or abdominal effusion
2)Uncontrolled hypertension
3)Uncontrolled heart disease
4)Evidence of Myocardial infarction witin 6 months
5)Active infection (except viral hepatitis)
6)Active gastrointestinal bleeding or ulcer
7)active double cancer
8)encephalopacy or severe mental disorder
9)severe drug allergy
10)pregnancy or lactaing females
11)inadequate for administration orally
12)Inadequate physical condition,as diagnosed by primary physician
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junji Furuse
Organization Kyorin University Hospital
Division name Department of Internal medicine, medical oncology
Zip code
Address 6-20-2 Shinkawa Mitakashi Tokyo
TEL 0422-47-5511
Email eisuzuki@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiichiro Suzuki
Organization Kyorin University Hospitl
Division name Department of Internal medicine, medical oncology
Zip code
Address 6-20-2 Shinkawa Mitakashi Tokyo
TEL +81-422-47-5511
Homepage URL
Email eisuzuki@ks.kyorin-u.ac.jp

Sponsor
Institute Kyorin University Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 01 Month 05 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 Main results already published
Date of protocol fixation
2009 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2012 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 04 Day
Last modified on
2019 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003606

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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