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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017688
Receipt No. R000020502
Scientific Title Feasibility and safty of CDDP-Microsphea TACE in epirbicin or miriplatin TACE refractory HCC with Child-Pugh score<8 patients.
Date of disclosure of the study information 2015/05/27
Last modified on 2017/11/26

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Basic information
Public title Feasibility and safty of CDDP-Microsphea TACE in epirbicin or miriplatin TACE refractory HCC with Child-Pugh score<8 patients.
Acronym CDDP-Microsphea TACE to epirbicin or miriplatin TACE refractory HCC
Scientific Title Feasibility and safty of CDDP-Microsphea TACE in epirbicin or miriplatin TACE refractory HCC with Child-Pugh score<8 patients.
Scientific Title:Acronym CDDP-Microsphea TACE to epirbicin or miriplatin TACE refractory HCC
Region
Japan

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

Objectives
Narrative objectives1 Feasibility and safty of CDDP-Microsphea TACE in epirbicin or miriplatin TACE refractory HCC with Child-Pugh score<8 patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Dose Limiting Toxicity and Recommended
Dose

Key secondary outcomes Objective response rate and disease control rate, frequency and severity of adverse event at recommended dose.

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 Device,equipment
Interventions/Control_1 cisplatin,microsphea
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)Histologicaly or clinicaly confirmed HCC.
(2)No indication of liver resection or RFA, PEI.
(3)Epirbicin-TACE or Miripratin-TACE refractory HCC.
(4)HCC without Vp3, Vp4, Vv2, Vv3,B3, B4.
(5)HCC without extrahepatic lesion.
(6)ECOG Performance Status 0-2
(7)Without dysfunction of liver, renal, coagulopathy.
(8)Child-Pugh score<8
(9)Without administration of CDDP and Microsphea.
(10)Written informed consent.
Key exclusion criteria (1)Massive type or infiltrative type of HCC.
(2)HCC supplied by extrahepatic artery.
(3)No hypersensitivity to contrast medium.
(4)Synchronous or metachronous malignancies within five years.
(5)Pregnant, lacting women or women with suspected pregnancy.
(6)Patients judged inappropriate for this study by physicians
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michihisa Moriguchi
Organization Kyoto Prefectural University of Medicine
Division name Gastroenterology and Hepatology
Zip code
Address Kawaramachi-Hirokoji, Kamigyou-ku, Kyoto
TEL 075-251-5111
Email mmori@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuya Seko
Organization Kyoto Prefectural University of Medicine
Division name Gastroenterology and Hepatology
Zip code
Address Kawaramachi-Hirokoji, Kamigyou-ku, Kyoto
TEL 075-251-5111
Homepage URL
Email yuyaseko@koto.kpu-m.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, 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)

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

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Terminated
Date of protocol fixation
2015 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 26 Day
Last modified on
2017 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020502

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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