UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of efficacy and safety of transcatheter arterial chemoembolization (TACE) with miriplatin for hepatocellular carcinoma.
Title of the study (Brief title)	Prospective study of TACE with miriplatin for 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 assess the efficacy and safety of transcatheter arterial chemoembolization with miriplatin for patients with hepatocellular carcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival, Child-Pugh status progression
Key secondary outcomes	Progression free survival, Tumor response, Safety

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 Maneuver
Interventions/Control_1	Transcatheter arterial chemoembolization with miriplatin
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 hepatocellular carcinoma as assessed by dynamic computed tomography or magnetic response imaging (ie, hypervascular with washout in the portal/venous phase) 3) No indication for surgical resection or liver transplantation 4) ECOG Performance Status 0-1 5) Adequate organ function a) Neutrophil>=1500 /mm3 b) Hb>= 9.0 g/dL c) PLT>= 50000 /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 6) Child-Pugh A or B 7) Adequate indication for TACE 8) Interval of at least 4 weeks between last treatment and start of present treatment 9) Life expectancy of at least 8 weeks 10) 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) Intrahepatic or portal-caval shunts 5) Tumor thrombosis in main portal vein or vena cava 6) Pregnant and lactating females; females of childbearing age unless using effective contraception 7) Patients who are concluded to be inappropriate to participate in this study by their physicians
Target sample size	200

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 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
Email

Public contact
Name of contact person
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular Gastroenterology and Hepatology
Address	465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Kyoto Prefectural University of Medicine
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)

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	2011 Year 07 Month 19 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 03 Month 03 Day
Anticipated trial start date	2011 Year 07 Month 01 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	2011 Year 07 Month 18 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=R000007092