UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009149 |
|---|---|
| Receipt number | R000010705 |
| Scientific Title | Efficacy and safety of transcatheter arterial chemoembolization using combination of epirubicin and miriplatin for hepatocellular carcinoma -Prospective comparative study with transcatheter arterial chemoembolization using epirubicin- |
| Date of disclosure of the study information | 2012/10/19 |
| Last modified on | 2016/04/19 09:36:44 |
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Basic information
Public title
Efficacy and safety of transcatheter arterial chemoembolization using combination of epirubicin and miriplatin for hepatocellular carcinoma
-Prospective comparative study with transcatheter arterial chemoembolization using epirubicin-
Acronym
TACE using combination of epirubicin&miriplatin for HCC
- Prospective comparative study with TACE using epirubicin-
Scientific Title
Efficacy and safety of transcatheter arterial chemoembolization using combination of epirubicin and miriplatin for hepatocellular carcinoma
-Prospective comparative study with transcatheter arterial chemoembolization using epirubicin-
Scientific Title:Acronym
TACE using combination of epirubicin&miriplatin for HCC
- Prospective comparative study with TACE using epirubicin-
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of trancatheter arterial chemoembolizaion (TACE) using combination of epirubicin and miriplatin for hepatocellular carcinoma and to compared with TACE using epirubicin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Anti-tumor effect
Safety
Key secondary outcomes
Tumor marker
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
(TACE using combination of epirubicin and miriplatin)
70mg miriplatin suspended in lipiodol and 20mg epirubicin dissolved in contrast medium are mixed, the preparation is injected through the catheter selectively introduced into the hepatic artery. Amount of lipiodol was decided by total tumor diameter and amount of contrast medium was mixed with 1/2 lipiodol volume.
Interventions/Control_2
(TACE using epirubicin)
40mg epirubicin dissolved in contrast medium and lipiodol are mixed, the preparation is injected through the catheter selectively introduced into the hepatic artery. Amount of lipiodol was decided by total tumor diameter and amount of contrast medium was mixed with 1/2 lipiodol volume.
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 with typical HCC diagnosed by histological or clinical examinations.
2) Patients without candidate for hepatectomy and ablation therapy.
3) Patients who are able to undergo TACE.
4) Child-Pugh score of 7 or less.
5) Patients aged 20 years or over.
6) ECOG performance status of 0-2.
7) Patients with measurable target lesion on Modified RECIST.
8) Patients with at least 4 weeks interval from previous hepatectomy, ablation therapy and TACE.
9) The function of the major organ is kept as satisfied, and laboratory values meet the following criteria within 14 days before study entry.
1.White blood cell>=3,000/mm3
2.Platelet>=50,000/uL
3.Hemogrobin>=8.0g/dL
4.Total serum bilirubin=<2.0mg/dL
5.AST and ALT=<5 times upper limits of normal
6.Prothrombin time(%)>=50%
7.Serum creatinine=<2.0mg/dL
8.No abnormal findings requiring treatment in the electrocardiogram.
10) Patients who are expected to live more than 3 months.
11) Patients obtained written informed consent except following key exclusion criteria.
Key exclusion criteria
1) History of previous treatment by platinum drugs.
2) Extrahepatic metastasis.
3) Advanced vascular or biliary invasion (Vp3, Vp4, Vv3, B3, B4).
4) Severe arterio-portal shunt or arterio-venous shunt.
5) Difficult to perform transcatheter arterial chemotherapy.
6) History of the biliary tract reconstruction or treatment.
7) Patients with following severe complicating disease(except chronic hepatitis and liver cirrhosis).
1. Heart failure
2. Renal failure(GFR:<15mL/min/1.73m2)
3. Active infections(except viral hepatitis)
4. Active gastrointestinal bleeding
5. Active duplicative cancer
6. Hepatic encephalopathy or severe mental illness
8) Fever>=38.0 degrees Celsius.
9) History of hypersensitivity to iodine-containing contrast agent, gadolinium-containing contrast agent, epirubicin and platinum-containing drug.
10) Patients who are pregnant, lactating, suspected to be pregnant, or wish to become pregnant.
11) Patients who are concluded to be inappropriate to undergo TACE by angiography.
12) Patients who are concluded to be inappropriate to participate in this study by their physicians.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Kaibori |
Organization
Kansai Medical University
Division name
Department of Surgery
Zip code
Address
2-3-1 Shinmachi, Hirakata, Osaka
TEL
072-804-0101
kaibori@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Kaibori |
Organization
Kansai Medical University
Division name
Department of Surgery
Zip code
Address
2-3-1 Shinmachi, Hirakata, Osaka
TEL
072-804-0101
Homepage URL
kaibori@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
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
| 2012 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 19 | 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
| 2012 | Year | 10 | Month | 19 | Day |
Last modified on
| 2016 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010705
