UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study on safety and efficacy of sorafenib as maintenance chemotherapy after percutaneous isolated hepatic perfusion chemotherapy (PIHP) for advanced hepatocellular carcinoma
Title of the study (Brief title)	A safety and efficacy of sorafenib as maintenance chemotherapy after percutaneous isolated hepatic perfusion (PIHP) for advanced hepatocellular carcinoma
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to analyze the safety and efficacy of sorafenib as maintenance therapy after percutaneous isolated hepatic perfusion (PIHP) for advanced hepatocellular carcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	One year overall survival
Key secondary outcomes	Progression or recurrence free survival Overall survival Safety of sorafenib administration after PIHP

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	After 4-8 weeks of PIHP, sorafenib therapy starts with a primary dose of 800mg/day. Sorafenib therapy continues until the appearance of unacceptable side effect or tumor 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients who underwent PIHP for advanced hepatocellular carcinoma 2)Patients who were diagnosed as hepatocellular carcinoma radiologically or pathologically 3)Patients who have no indication of surgical resection, local therapy (RFA, TACE, percutaneous ethanol injection) 4)Patients who satisfy the criteria of sorafenib administration 5)Patients who approve sorafenib therapy and sign a document for it.
Key exclusion criteria	1)Patients with a history of molecular- target therapy including sorafenib. 2)Patients with a history of hypersensitivity of sorafenib 3)Patients who are pregnant or on nurse. 4)Patients who are on dialysis 5)Patients with uncontrolled hypertension 6)Patients with a history of thrombosis, embolism, or ischemic Heart Disease 7)Patients with brain metastasis 8)Patients with esophageal varix with bleeding tendency 9)Patients with gastrointestinal bleeding within one month 10)Patients with ongoing or history of hepatic encephalopathy 11)Patients who undergo rifampin 12)Patients with HIV or AIDS 13)Patients with synclonous double cancer
Target sample size	30

Research contact person
Name of lead principal investigator	Fukumoto Takumi
Organization	Kobe University
Division name	Department of hepato-biliary-pancreatic surgery
Address	7-5-2, Kusunokicho, Chuo-Ku, Kobe, Japan
TEL	078-382-6302
Email	fukumoto@med.kobe-u.ac.jp

Public contact
Name of contact person	Motofumi Tanaka
Organization	Kobe University
Division name	Department of hepato-biliary-pancreatic surgery
Address	7-5-2, Kusunokicho, Chuo-Ku, Kobe, Japan
TEL	078-382-6302
Homepage URL
Email	motofutanaka-gi@umin.net

Sponsor
Institute	Department of hepato-biliary-pancreatic surgery, Kobe University
Institute
Department

Funding Source
Organization	Bayer Pharma
Organization
Division
Category of Funding Organization	Profit organization
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	Kobe University Graduate School of Medicine

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 15 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date	2017 Year 01 Month 19 Day
Date of closure to data entry
Date trial data considered complete	2017 Year 01 Month 19 Day
Date analysis concluded	2017 Year 01 Month 31 Day

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

Management information
Registered date	2012 Year 08 Month 15 Day
Last modified on	2018 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008809