UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006926 |
|---|---|
| Receipt number | R000008183 |
| Scientific Title | Prospective study of efficacy, safety and pharmacokinetics of transcatheter arterial chemoembolization (TACE) with miriplatin for hepatocellular carcinoma. |
| Date of disclosure of the study information | 2011/12/21 |
| Last modified on | 2018/12/25 16:42:01 |
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Basic information
Public title
Prospective study of efficacy, safety and pharmacokinetics of transcatheter arterial chemoembolization (TACE) with miriplatin for hepatocellular carcinoma.
Acronym
Study for evaluating efficacy, safety and pharmacokinetics of TACE with miriplatin in the treatment of patients with HCC.
Scientific Title
Prospective study of efficacy, safety and pharmacokinetics of transcatheter arterial chemoembolization (TACE) with miriplatin for hepatocellular carcinoma.
Scientific Title:Acronym
Study for evaluating efficacy, safety and pharmacokinetics of TACE with miriplatin in the treatment of patients with HCC.
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma (HCC)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety, efficacy and pharmacokinetics of TACE with miriplatin for HCC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Tumor response (Treatment effect: TE)
Key secondary outcomes
Tumor marker change, overall survival, safety, pharmacokinetics (plasma Pt conc.)
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
TACE 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)Patients who were provided written informed consent.
2)Life expectancy of at least 12 weeks.
3)Histologically proven or clinically diagnosed hepatocellular carcinoma (dynamic CT/MRI).
4)No indication for surgical resection and local ablation.
5)Locally nodular disease without extrahepatic metastasis. Number of tumors are up to 5 (The maximum tumor diameter <= 5 cm).
6)Patients with no or one history of TACE therapy.
7)Performance status (ECOG) of 0-2
8)Child-Pugh class A or B.
9)Patients who fulfill of the inclusion criteria below.
a) Hemoglobin >= 8.5 g/dl
b) Neutrophil >=1,500 /mm3
c) PLT >= 50,000 /mm3
d) T.Bil <=3.0mg/dl
e) ALT, AST <= within 6 times of normal limit
f) Cre <= within 1.5 times of normal limit
Key exclusion criteria
1)History of malignant tumor
2)Serious and active infection, except for HBV and HCV
3)History of HIV infection
4)Renal dialysis
5)Diffuse tumor lesion
6)Extrahepatic metastasis
7)Vascular invasion
8)Intracranial tumor
9)Clinically uncontrolled ascites or pleural effusion
10)Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment
11)Esophageal and/or gastric varices which has high risk of bleeding
12)History of thrombosis and/or embolism within 6 months of the start of treatment
13)History of receiving any of the following therapies:
a)Systemic chemotherapy for advanced HCC
b)Local therapy within 3 months of the start of treatment
c)Invasive surgery within 4 weeks of the start of treatment
d)History of allogenic transplantation
e)History of bone marrow transplant or haemopoietic stem cell transplant within 4 weeks of the start of this study
14)Concurrent disease or disability that may affect evaluation of the effects of the study drugs
15)Enrollment in another study within 4 weeks of study entry
16)Female patients who are pregnant, lactating, possibly pregnant, or planning to become pregnant
17)Risk of allergic reactions to the study drugs
18)Drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results
19)Any condition that could jeopardize the safety of the patient or their compliance in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Hino |
Organization
Kawasaki Medical School
Division name
Department of Hepatology and Pancreatology
Zip code
Address
577 Matsushima, Kurashiki, Okayama, 701-0192, Japan
TEL
086-462-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Tomiyama |
Organization
Kawasaki Medical School
Division name
Department of Hepatology and Pancreatology
Zip code
Address
577 Matsushima, Kurashiki, Okayama, 701-0192, Japan
TEL
086-462-1111
Homepage URL
Sponsor or person
Institute
Kawasaki Medical School
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 | 12 | Month | 21 | 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 | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 21 | Day |
Last modified on
| 2018 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008183
