UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014961 |
|---|---|
| Receipt number | 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 18:55:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
takayama@tokushima-u.ac.jp
Sponsor or person
Institute
tokushima university
Institute
Department
Personal name
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
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
Value
https://center6.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 |
