UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of sorafenib and radiation therapy for advanced hepatocellular carcinoma with portal vein thrombosis
Title of the study (Brief title)	Sorafenib and radiation therapy for hepatocellular carcinoma
Region	Japan

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

Objectives
Narrative objectives1	To assess the safety and efficacy of sorafenib and radiation therapy for advanced hepatocellular carcinoma with portal vein thrombosis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety Overall survival
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 Radiation
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) Histologically proven or clinically diagnosed hepatocellular carcinoma 2) Typical features of tumor thrombus as assessed by dynamic computed tomography or magnetic response imaging 3) No indication for surgical resection, liver transplantation, and local therapy 4) ECOG Performance Status 0-1 5) Child-Pugh classification A 6) Adequate organ function a) Neutrophil>=1500 /mm3 b) Hb>= 9.0 g/dL c) PLT>= 60000 /mm3 d) T-Bil<= 3.0 mg/dL e) Albumin>= 2.8 g/dL f) AST<= within 5 times of normal limit g) ALT<= within 5 times of normal limit h) Cre<= within 1.5 times of normal limit 7) Written informed consent
Key exclusion criteria	1) Refractory pleural effusion or ascites 2) Encephalopathy 3) Concurrent disease a) Serious hypertension b) Severe heart disease c) Acute myocardial infarction within 6 months prior to inclusion d) Active double cancer e) Severe mental disorder f) Allergic reaction to iodine contrast material g) Severe drug allergy 4) Pregnant and lactating females; females of childbearing age unless using effective contraception 5) Patients who are concluded to be inappropriate to participate in this study by their physicians
Target sample size	6

Research contact person
Name of lead principal investigator	Kohichiroh Yasui
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular Gastroenterology and Hepatology
Address	465 Kawaramachi Hirokoji Kamigyo-ku, Kyoto 602-8566, Japan
TEL
Email

Public contact
Name of contact person
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular Gastroenterology and Hepatology
Address
TEL
Homepage URL
Email

Sponsor
Institute	Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	京都府立医科大学附属病院（京都府）

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 16 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 01 Month 12 Day
Anticipated trial start date	2011 Year 01 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 06 Month 16 Day
Last modified on	2018 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009644