UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028000
Receipt No. 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

* 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
Last 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
Email toyotan@kure-nh.go.jp

Public contact
1st 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
Email ishikawam@kure-nh.go.jp

Sponsor
Institute National Hospital Organization KURE Medical Center
Institute
Department

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
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
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
URL(English) https://upload.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


Contact us.