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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014961
Receipt No. R000017412
Scientific Title dose-finding study of miriplatin arterial injection therapy for advanced hepatocellular carcinoma
Date of disclosure of the study information 2014/08/31
Last modified on 2015/02/26

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Basic information
Public title dose-finding study of miriplatin arterial injection therapy for advanced hepatocellular carcinoma
Acronym dose-finding study of miriplatin arterial injection therapy for advanced hepatocellular carcinoma
Scientific Title dose-finding study of miriplatin arterial injection therapy for advanced hepatocellular carcinoma
Scientific Title:Acronym dose-finding study of miriplatin arterial injection therapy for advanced hepatocellular carcinoma
Region
Japan

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

Objectives
Narrative objectives1 investigate the optimal amount ratio of miriplatin-lipiodol and consider the safety and efficacy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes responce rate
Key secondary outcomes The extent and frequency of occurrence of adverse events and survival rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 intra-arterial injection of miriplatin suspension from the hepatic artery
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 Patients diagnosed with hepatocellular carcinoma clinical such as angiography, CT, and MRI or histologically
Patients with off-label liver resection, PEI and RFA
Patient had never received chemotherapy TAE. PEI or liver resection, RFA is acceptable. However, PEI , RFA and post-stump recurrence after hepatectomy I will improper local recurrence.
Child Pugh A or B
Patients must be expected to survive more than two months at least
organ function below, the patient sufficient bone marrow, renal, cardiovascular is maintained. Liver has sufficient compensatory physiologically function.
WBC or more 3,000 per micro litter
PLT or more 50000/micro litter
Hb or more 9.5g/micro litter
AST or less 200 U/L
ALT or less 200 U/L
Serum bilirubin or less 3mg/dL
Serum creatinine or less facility upper limit of normal
Patients to confirm that it also has a structure of appropriate hepatic artery for catheter insertion selective
the general state, Performance Status is of 0, 1, and 2 patients
The elapsed more than 4 weeks at least from before treatment, liver resection, the RFA or PEI, patients without the influence of prior treatment
Key exclusion criteria (1) Patients with a history of hypersensitivity to contrast agent or drug, including Iodine
(2) Patients with (thyroid disease particularly severe, severe cardiac disease) complications
(3) serious Patients with double cancer activity
(4) Patients with intrahepatic shunt
(5) Patients with distant metastases
(6) Patients with intention of pregnancy, pregnant women, and lactating women
(7) Patients with investigator or investigator was found to be inappropriate as a target
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name tanayama tetsuji
Organization university of tokushima graduate school
Division name department of gastroenterology and oncology, instituteof health bioscience
Zip code
Address 18-15, Kuramoto-cho 3-chome, Tokushima city, Tokushima Prefecture
TEL 088-633-7124
Email takayama@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name tanaka hironori
Organization university of tokushima graduate school
Division name department of gastroenterology and oncology, instituteof health bioscience
Zip code
Address 18-15, Kuramoto-cho 3-chome, Tokushima city, Tokushima Prefecture
TEL 088-633-7124
Homepage URL
Email takayama@tokushima-u.ac.jp

Sponsor
Institute tokushima university
Institute
Department

Funding Source
Organization tokushima university
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
2014 Year 08 Month 31 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
2014 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2014 Year 09 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
2014 Year 08 Month 26 Day
Last modified on
2015 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017412

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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