UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027941 |
|---|---|
| Receipt number | R000029633 |
| Scientific Title | Exploratory research on efficacy and safety of transarterial chemo-embolization with warmed miriplatin for unresectable hepatocellular carcinoma |
| Date of disclosure of the study information | 2017/06/28 |
| Last modified on | 2024/03/12 10:43:31 |
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Basic information
Public title
Exploratory research on efficacy and safety of transarterial chemo-embolization with warmed miriplatin for unresectable hepatocellular carcinoma
Acronym
efficacy and safety of TACE with warmed miriplatin for unresectable HCC
Scientific Title
Exploratory research on efficacy and safety of transarterial chemo-embolization with warmed miriplatin for unresectable hepatocellular carcinoma
Scientific Title:Acronym
efficacy and safety of TACE with warmed miriplatin for unresectable HCC
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of transarterial chemo-embolization with warmed miriplatin for unresectable hepatocellular carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response rate (CR + PR) by contrast-enhanced CT or MRI between 1 and 2 months after TACE based on the modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Transarterial chemo-embolization using warmed 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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) patient with hepatocellular carcionoma, not candidate for surgery or ablation therapy
2) patient with hypervascular HCC in imaging study (CT, MRI, US)
3) age 20 years old and over, under 85 years old
4) written informed consent with patient him/herself
Key exclusion criteria
1) severly impaired liver function (Child-Pugh C)
2) jaundice with T-bil >=3mg/dL
3) severely impaired renal function (eGFR < 30 mL/min/1.73m2)
4) past history with allergy or severe adverse events after TACE
5) marked history of hypersensitivity to miriplatin, other platinum-containing drugs or iodine-containing drugs
6) uncontrolled severe thyroid disorder
7) pregnant, lactating
8) dementia with difficuty conducting TACE
9) patients judged inadequate by investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeyuki |
| Middle name | |
| Last name | Watadani |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Radiology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-8666
watadat-tky@umin.net
Public contact
Name of contact person
| 1st name | Takeyuki |
| Middle name | |
| Last name | Watadani |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Radiology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-8666
Homepage URL
watadat-tky@umin.net
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo
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
Ethical committee, The University of Tokyo, Faculty of Medicine
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-3303
ethics@m.u-tokyo.ac.jp
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
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 28 | 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
| 2017 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | 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
| 2017 | Year | 06 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029633
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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