UMIN-CTR Clinical Trial

Basic information
Public title	Hepatic arterial infusion chemotherapy in patients with advanced hepatocellular carcinoma: Prospective randomized study
Acronym	HAIC for advanced HCC
Scientific Title	Hepatic arterial infusion chemotherapy in patients with advanced hepatocellular carcinoma: Prospective randomized study
Scientific Title:Acronym	HAIC 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 investiated the efficacy of combination therapy with desferoxamine and sorafenib in advanced hepatocellular carcinoma patients who were non-responders for hepatic arterial infusion chemotherapy with anticancer drugs in prospective randomized study.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Combination therapy with desferoxamine and sorafenib
Interventions/Control_2	Sorafenib only
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 and indication for sorafenib 3) Patients who have no influence on previous treatment 4) Performance status(PS) 0 or 1 5) Child-Pugh A 6) Favorable function of major organs (bone marrow, kidney, heart), and meeting citeria as follows: (1) neutrophil count >= 1500/mm3 (2) platelet count>= 50000/mm3 (3) hemogrobin level >= 8.5g/dl (4) serum creatinine level < 2mg/dl (5) prothrombin time activity >= 50% (6) age >= 20years, male and female
Key exclusion criteria	1) Severe coexisting illness (expect for chronic hepatitis or liver cirrhosis) 2) Active bouble cancers 3) serum creatinine level >= 2mg/dl 4) Past history of hypersensitivity for drugs including iodine and contrast agent 5) Patients with pregnancy, lactation or possibility of pregnancy 6) Patients who judged as inadequacy due to other reasons by the doctor
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takahiro Yamasaki
Organization	Yamaguchi University School of Medicine
Division name	First Department of Internal Medicine
Zip code
Address	1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Yamaguchi University School of Medicine
Division name	First Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email	t.yama@yamaguchi-u.ac.jp

Sponsor
Institute	First Department of Internal Medicine, 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
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	2011 Year 09 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	Terminated
Date of protocol fixation	2011 Year 05 Month 09 Day
Date of IRB	2011 Year 05 Month 16 Day
Anticipated trial start date	2011 Year 07 Month 01 Day
Last follow-up date	2016 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	2011 Year 06 Month 07 Day
Last modified on	2020 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006776