UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013451 |
|---|---|
| Receipt number | 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 09:52:11 |
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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
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
issaeki@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University School of Medicine
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
Institutional Review Boards of the Yamaguchi University Hospital
Address
Minami kogushi 1-1-1, Ube, Yamaguchi, Japan
Tel
0836-22-2428
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
Value
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
