UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of sorafenib in patients with advanced hepatocellular carcinoma
Title of the study (Brief title)	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	Junji Furuse
Organization	Kyorin University Hospital
Division name	Department of Internal medicine, medical oncology
Address	6-20-2 Shinkawa Mitakashi Tokyo
TEL	0422-47-5511
Email	eisuzuki@ks.kyorin-u.ac.jp

Public contact
Name of contact person	Eiichiro Suzuki
Organization	Kyorin University Hospitl
Division name	Department of Internal medicine, medical oncology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2009 Year 10 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000003606