UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028000 |
|---|---|
| Receipt number | R000032033 |
| Scientific Title | A phase 2 study of transcatheter aterial chemoembolization using cisplatin and DC beads for advanced hepatocellular carcinoma |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2018/06/29 16:04:58 |
* 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
A phase 2 study of transcatheter aterial chemoembolization using cisplatin and DC beads for advanced hepatocellular carcinoma
Acronym
DEB-TACE(CDDP+DC beads)
Scientific Title
A phase 2 study of transcatheter aterial chemoembolization using cisplatin and DC beads for advanced hepatocellular carcinoma
Scientific Title:Acronym
DEB-TACE(CDDP+DC beads)
Region
| Japan |
Condition
Condition
HCC
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the transcatheter arterial chemoembolization using cisplatic and DC beads in patients with HCC not capable of local therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate(RR) 3 months after TACE
Key secondary outcomes
Safty
Tumor markers
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
Transcatheter arterial chemoembolization using cisplatin and DC beads
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 with HCC diagnosed by histological or crinical examinations.
(2)HCC with enhancement in arterial phase of enhanced CT or MRI.
(3)Child-Puge score of 7 or less.
(4)multiple HCC or sigle HCC over 5cm diameter
(5) PS 0-2
(6)patients aged 20 years or over.
(7)HCC not capable of local therapy.
(8)Patients with at least 4 weeks interval from previous local therapy or transcatheter therapy.
(10)Patients who are expected to live more than 3 months.
Key exclusion criteria
(1)HCC without stain on angiogram.
(2)History of hypersensitivity to cisplatinum-containing drug.
(3)distant metastasis
(4)main portal tumor thrombosis or hepatic vein tumor thrombosis
(5)Patients with intrahepatic AP shunt or AV shunt.
(6)Patients with complications to be treated preferentially.
(7)Patients who can not keep their rest during the procedure.
(8)Patients who are concluded to be inappropriate to participate in this study by their physicians.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoyuki Toyota |
Organization
National Hospital Organization KURE Medical Center
Division name
Diagnostic radiology
Zip code
Address
3-1, Aoyama-cho, Kure, Hiroshima
TEL
0823-22-3111
toyotan@kure-nh.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Ishikawa |
Organization
National Hospital Organization KURE Medical Center
Division name
Diagnostic radiology
Zip code
Address
3-1, Aoyama-cho, Kure, Hiroshima
TEL
0823-22-3111
Homepage URL
ishikawam@kure-nh.go.jp
Sponsor or person
Institute
National Hospital Organization KURE Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization KURE Medical Center
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
| 2017 | Year | 08 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 13 | 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
| 2017 | Year | 06 | Month | 29 | Day |
Last modified on
| 2018 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032033
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/06/29 | (最新版)研究計画書 Ver2.0(DEB-TACE).docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2018/01/04 | 症例登録書 2017-6-27.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
