UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015545