UMIN-CTR Clinical Trial

Basic information
Public title	Phase 1 study of sorafenib and hepatic arterial infusion chemotherapy with Miriplatin for advanced Hepatocellular carcinoma.
Acronym	Phase 1 study of sorafenib and Miriplatin for advanced HCC.
Scientific Title	Phase 1 study of sorafenib and hepatic arterial infusion chemotherapy with Miriplatin for advanced Hepatocellular carcinoma.
Scientific Title:Acronym	Phase 1 study of sorafenib and Miriplatin for advanced HCC.
Region	Japan

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

Objectives
Narrative objectives1	This study assessed the safety and efficacy of sorafenib and Miriplatin for advanced HCC.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Complication
Key secondary outcomes	Response evaluation , 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	Administration via the catheater inserted into the hepatic artery or the implanted port of Miriplatin(65mg/m2,ia,/day) / 4 weeks. And administration sorafenib( 400~800mg /body/day ) at once.
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Histrogically or clinically confirmed hepatocellular carcinoma. 2.Advanced HCC no indication for liver transplantation or hepatic resection. 3.Age : 20 years old <= 4.EOCG performance status is 0 or 1. 5.Life expectancy is more than 3 months. 6.Sufficient function of main organ and conditions filled the following criteria. WBC : 2000 /mm3L <= Hb : 8.5 g/dL <= Plt : 50000 / mm3L <= S-Total Bilirubin : 2.0 mg/dL >= S-Albumin : 3.0 g/dL<= S-Creatinine : 1.5 mg/dL >= Without uncontrolled ascites and hepatic encephalopathy Ejection fraction : 45% <= PaO2 : 60mmHg <= 7.Written informed consent was obtained.
Key exclusion criteria	1.Previous hepatic resection or RFA within 4 weeks. 2.Patients with active double cancers. 3.Patients with concurrent infections 4.Patients with hypersensitivity to Miliplatin and contrast medium of iodine. 5.Pregnant, lacting women or women with suspected pregnancy. 6.Inappropriate patients for this study judged by physicians.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Michio Sata
Organization	Kurume university School of Medicine
Division name	Division of Gastroenterology
Zip code
Address	67, Asahi-machi,Kurume-city,Fukuoka,830-0011, Japan
TEL	0942-31-7561
Email	ymhp0389@yamehp.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroaki Nagamatsu
Organization	Yame General Hospital
Division name	Department of Hepatology
Zip code
Address	540-2,Takatsuka,Yame-city,Fukuoka,834-0034,Japan
TEL	0943-23-4131
Homepage URL
Email	ymhp0389@yamehp.jp

Sponsor
Institute	Division of Gastroenterology,Kurume university School 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)

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	公立八女総合病院(福岡県)

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	10 patients were registrated this study, 27, Feb, 2014 Liver disfunction: 4patients ascites :2patients SD / PD : 3 / 7 patients MST : 7.3 months
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	Completed
Date of protocol fixation	2012 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2012 Year 09 Month 01 Day
Last follow-up date	2014 Year 08 Month 31 Day
Date of closure to data entry	2015 Year 08 Month 31 Day
Date trial data considered complete	2015 Year 08 Month 31 Day
Date analysis concluded	2015 Year 08 Month 31 Day

Other
Other related information	VEGF of 1 month later starting the protocol < 100pg/mL : 3 patients 100pg/mL : 7 patients

Management information
Registered date	2012 Year 08 Month 27 Day
Last modified on	2016 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010320

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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