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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013451
Receipt No. R000015545
Scientific Title Deferasirox for patients with advanced hepatocellular carcinoma : pilot study
Date of disclosure of the study information 2014/04/01
Last modified on 2021/03/23

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Basic information
Public title Deferasirox for patients with advanced hepatocellular carcinoma : pilot study
Acronym DFX for advanced HCC
Scientific Title Deferasirox for patients with advanced hepatocellular carcinoma : pilot study
Scientific Title:Acronym DFX for advanced HCC
Region
Japan

Condition
Condition advanced hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We investigated the safety of deferasirox in advanced hepatocellular carcinoma patients who were non-responders for chemotherapy with anticancer drugs in pilot study.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety
Key secondary outcomes Survival, Response, Progression-free survival

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 Deferasirox
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 advanced hepatocellular carcinoma
2) Non-responders for chemotherapy with anticancer drugs
3) Patients who have no influence on previous treatment
4) Performance status(PS) 0 or 1
5) Child-Pugh A or B
6) Favorable function of major organs (bone marrow, kidney, heart), and meeting criteria as follows:
(1) WBC >= 2500/mm3
(2) platelet count>= 50000/mm3
(3) hemogrobin level >= 9.0g/dl
(4) total bilirubin <= 3.0mg/dl
(5) serum creatinine level < 2mg/dl
(6) BUN <= 25mg/dl
(7) prothrombin time activity >= 50%
7) age >= 20years, male and female
Key exclusion criteria 1) Severe coexisting illness (expect for chronic hepatitis or liver cirrhosis)
2) Active double cancers
3) Past history of hypersensitivity for drugs including iodine and contrast agent
4) Patients with pregnancy, lactation or possibility of pregnancy
5) Past history of interstitial pneumonia
6) Chronic respiratory failure
7) Patients who judged as inadequacy due to other reasons by the doctor
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Issei
Middle name
Last name Saeki
Organization Yamaguchi University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 755-8505
Address 1-1-1 Minamikogushi, Ube, Yamaguchi
TEL 0836-22-2241
Email issaeki@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name Issei
Middle name
Last name Saeki
Organization Yamaguchi University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 755-8505
Address 1-1-1 Minamikogushi, Ube, Yamaguchi
TEL 0836-22-2241
Homepage URL
Email issaeki@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University School of Medicine
Institute
Department

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 Institutional Review Boards of the Yamaguchi University Hospital
Address Minami kogushi 1-1-1, Ube, Yamaguchi, Japan
Tel 0836-22-2428
Email me223@yamaguchi-u.ac.jp

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 04 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 Completed
Date of protocol fixation
2014 Year 02 Month 12 Day
Date of IRB
2014 Year 03 Month 01 Day
Anticipated trial start date
2014 Year 03 Month 10 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 18 Day
Last modified on
2021 Year 03 Month 23 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015545

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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