UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005995 |
|---|---|
| Receipt number | R000007092 |
| Scientific Title | Prospective study of efficacy and safety of transcatheter arterial chemoembolization (TACE) with miriplatin for hepatocellular carcinoma. |
| Date of disclosure of the study information | 2011/07/19 |
| Last modified on | 2018/06/21 10:18:19 |
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Basic information
Public title
Prospective study of efficacy and safety of transcatheter arterial chemoembolization (TACE) with miriplatin for hepatocellular carcinoma.
Acronym
Prospective study of TACE with miriplatin for hepatocellular carcinoma.
Scientific Title
Prospective study of efficacy and safety of transcatheter arterial chemoembolization (TACE) with miriplatin for hepatocellular carcinoma.
Scientific Title:Acronym
Prospective study of TACE with miriplatin for hepatocellular carcinoma.
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of transcatheter arterial chemoembolization with miriplatin for patients with hepatocellular carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival, Child-Pugh status progression
Key secondary outcomes
Progression free survival, Tumor response, Safety
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 | Maneuver |
Interventions/Control_1
Transcatheter arterial chemoembolization with miriplatin
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) Histologically proven or clinically diagnosed hepatocellular carcinoma
2) Typical features of hepatocellular carcinoma as assessed by dynamic computed tomography or magnetic response imaging (ie, hypervascular with washout in the portal/venous phase)
3) No indication for surgical resection or liver transplantation
4) ECOG Performance Status 0-1
5) Adequate organ function
a) Neutrophil>=1500 /mm3
b) Hb>= 9.0 g/dL
c) PLT>= 50000 /mm3
d) T-Bil<= 3.0 mg/dL
e) Albumin>= 2.8 g/dL
f) AST<= within 5 times of normal limit
g) ALT<= within 5 times of normal limit
h) Cre<= within 1.5 times of normal limit
6) Child-Pugh A or B
7) Adequate indication for TACE
8) Interval of at least 4 weeks between last treatment and start of present treatment
9) Life expectancy of at least 8 weeks
10) Written informed consent
Key exclusion criteria
1) Refractory pleural effusion or ascites
2) Encephalopathy
3) Concurrent disease
a) Serious hypertension
b) Severe heart disease
c) Acute myocardial infarction within 6 months prior to inclusion
d) Active double cancer
e) Severe mental disorder
f) Allergic reaction to iodine contrast material
g) Severe drug allergy
4) Intrahepatic or portal-caval shunts
5) Tumor thrombosis in main portal vein or vena cava
6) Pregnant and lactating females; females of childbearing age unless using effective contraception
7) Patients who are concluded to be inappropriate to participate in this study by their physicians
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohichiroh Yasui |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
Homepage URL
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
| 2011 | Year | 07 | Month | 19 | 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
| 2011 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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
| 2011 | Year | 07 | Month | 18 | Day |
Last modified on
| 2018 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007092
