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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010291
Receipt No. R000012029
Scientific Title Efficacy of transcatheter arterial chemoembolization (TACE) with miriplatin for multiple hepatocellular carcinoma refractory or inappropriate to conventional TACE
Date of disclosure of the study information 2013/04/01
Last modified on 2013/09/27

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Basic information
Public title Efficacy of transcatheter arterial chemoembolization (TACE) with miriplatin for multiple hepatocellular carcinoma refractory or inappropriate to conventional TACE
Acronym Efficacy of transcatheter arterial chemoembolization (TACE) with miriplatin for multiple hepatocellular carcinoma refractory or inappropriate to conventional TACE
Scientific Title Efficacy of transcatheter arterial chemoembolization (TACE) with miriplatin for multiple hepatocellular carcinoma refractory or inappropriate to conventional TACE
Scientific Title:Acronym Efficacy of transcatheter arterial chemoembolization (TACE) with miriplatin for multiple hepatocellular carcinoma refractory or inappropriate to conventional TACE
Region
Japan

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

Objectives
Narrative objectives1 To assess the efficacy of transcatheter arterial chemoembolizaion (TACE) with miriplatin for multiple hepatocellular carcinoma refractory or inappropriate to cisplatin or epirubicin -TACE.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Response rate
(based on RECICL or mRECIST)
Key secondary outcomes Progression free survival
Disease control rate
Safety
1y survival rate

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 Miriplatin-TACE
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) HCC histologically or clinically confirmed
2) Patients with multiple HCCs that are diagnosed as stageII-IVA and are not indication for surgical resection or local ablation
3) Patients without severe tumor thrombosis in the portal vein, hepatic vein or the bile duct
*severe tumor thrombosis (Vp3, Vp4, Vv3)
4) Patients under Child-Pugh A or B
5) Patients under PS 0 or 1
6) Patients who fulfill following A) or B)
A) In active clinical trial (C-385, UMIN ID:UMIN000003162), refractory patients to cisplatin or epirubicin-TACE.
B) In active clinical trial (C-385, UMIN ID:UMIN000003162), inappropriate patients and patients who fulfill all of the selected criteria below
1.CRE<2.0mg/dl
(In active clinical trial, CRE=<1.2mg/dl)
2.WBC>=3000/mm3
3.Plt>=5x10^4/mm3
4.Hb>=8.0g/dl
5.T-Bil=<3.0mg/dl
Key exclusion criteria 1) Patients with another active cancer
2) Patients with extrahepatic metastasis
3) Patients with prior surgical reconstruction of the biliary tract or prior endoscopic treatment of ampulla of vater
4) Patients with clinically significant refractory ascites or pleural effusion
5) Patients with hepatic encephalopathy
6) Patients with severe co-morbidity such as cardiac failure and renal failure
7) Patients with a medical history of severe hypersensitivity
8) Patients who are pregnant, lactating or are suspected to be pregnant.
9) Patients who are concluded to be inappropriate to participate in this study by their physicians
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Etsuro Hatano
Organization Graduate School of Medicine Kyoto University
Division name Department of Surgery
Zip code
Address 54 Kawaharacho Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3608
Email etsu@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Kasai
Organization Graduate School of Medicine Kyoto University
Division name Department of Surgery
Zip code
Address 54 Kawaharacho Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3608
Homepage URL
Email shiryou@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Surgery, Graduate School of Medicine Kyoto University
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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 01 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 Enrolling by invitation
Date of protocol fixation
2013 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 21 Day
Last modified on
2013 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012029

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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