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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008782
Receipt No. R000010320
Scientific Title Phase 1 study of sorafenib and hepatic arterial infusion chemotherapy with Miriplatin for advanced Hepatocellular carcinoma.
Date of disclosure of the study information 2012/09/01
Last modified on 2016/08/31

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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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