UMIN-CTR Clinical Trial

Basic information
Public title	Randomized contorol trial of transarterial chemoinfusion with cisplatin-lipiodol susupension or miriplatin-lipiodol suspension for advanced HCC
Acronym	Randomized contorol trial of transarterial chemoinfusion for advanced HCC
Scientific Title	Randomized contorol trial of transarterial chemoinfusion with cisplatin-lipiodol susupension or miriplatin-lipiodol suspension for advanced HCC
Scientific Title:Acronym	Randomized contorol trial of transarterial chemoinfusion for advanced HCC
Region	Japan

Condition
Condition	Hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare with the efficacy and safety on trasarterial chemoinfusion between miriplatin-lipiodol suspension and cisplatin-lipiodol suspension with advanced HCC
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Overall survival Safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Miriplatin-lipiodol suspension group:Powdered miriplatin(70mg) suspended in lipiodol(6ml) is injected through the catheter selectively introduced into the hepatic artery,The doses of suspension are determined according to filled a tumor artery.and upper limitation is 140mg as miriplatin. If the patients need repeated therapy ,they are treated at the interval of 4weeks
Interventions/Control_2	Cisplatin-lipiodol suspension group:Powdered cisplatin(50mg) suspended in lipiodol(6ml) is injected through the catheter selectively introduced into the hepatic artery,The doses of suspension are determined according to filled a tumor artery.and upper limitation is 100mg as cisplatin. If the patients need repeated therapy ,they are treated at the interval of 4weeks
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Histologically or clinically comfirmed Hepatocellular carcinoma 2)Patients diagnosed as stage2-3 3)Interval of 4 weeks or over between last treatment and present therapy 4)Child-pugh is A or B 5)No indication for surgical resection or local ablation 6)PS is 0,1 or 2 7)Sufficient functions of main organ(bone marrow,kidney,heart)and conditions filled a following criteria 1 WBC>=2,000 /mm3,<=10,000 /mm3 2 Plt>=50,000 /mm3 3 Hb>=8.0 g/dL 4 T-Bil<=3.0 mg/dL 5 PT>=50% 6 Creatinine<=1.5 mg/dL 7 BUN<=35 mg/dL 8)Age is more than 20 years old and below 80 years old 9)Patients obtained written infoemed consent
Key exclusion criteria	1)Patienta with sever co-morbidity such as cardiac failure or renal failure 2)Patienta with a medical history of severe hypersensitivity 3)Patients who are pregnant,lactating or are suspected to be a pregnant 4)Patients who are concluded to be inappropriate to participate in this study by their physitians
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Koji Middle name Last name Takai
Organization	Gifu University Hospital
Division name	First Department of Internal Medicine
Zip code	501-1194
Address	1-1 Yanagido Gifu 501-1194
TEL	058-230-6000
Email	koz@gifu-u.ac.jp

Public contact
Name of contact person	1st name Koji Middle name Last name Takai
Organization	Gifu University Hospital
Division name	First Department of Internal Medicine
Zip code	5011194
Address	yanagido1-1,gifu,gifu
TEL	058-230-6000
Homepage URL
Email	koz@gifu-u.ac.jp

Sponsor
Institute	First Department of Internal Medicine,Gifu University Hospital
Institute
Department

Funding Source
Organization	First Department of Internal Medicine,Gifu University Hospital
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	IRB Gifu medical university
Address	1-1 Yanagido Gifu 501-1194
Tel	058-230-6000
Email	gjme00004@jim.gifu-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	岐阜市民病院（岐阜県）　岐阜県総合医療センター（岐阜県）　中濃厚生病院（岐阜県）

Other administrative information
Date of disclosure of the study information	2010 Year 05 Month 01 Day

Related information
URL releasing protocol	2015 May;45(5):514-22. doi: 10.1111/hepr.12376. Epub 2014 Jul 24.
Publication of results	Published

Result
URL related to results and publications	2015 May;45(5):514-22. doi: 10.1111/hepr.12376. Epub 2014 Jul 24.
Number of participants that the trial has enrolled	98
Results	The 1-year survival rates in the cisplatin and miriplatin groups were 84.0% and 77.7%, and the 2-year survival rates were 60.0% and 51.8% respectively. (P = 0.905).The 1-year survival rates in the cisplatin and miriplatin groups with TAI alone were 71.4% and 71.4%, and the 2-year survival rates cannot be calculated yet. (P = 0.695).TE evaluation, the 1-year survival rates in TE3+4 and TE1+2 groups were 100% and 62.1%, and the 2-year survival rates were 66.7% and 33.1% respectively. (P = 0.0263).
Results date posted	2021 Year 10 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	diagnosis of HCC by histology or contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI)
Participant flow	After admission, patients were randomly assigned to either the cisplatin or miriplatin group before undergoing angiography. Balanced randomization was carried out by employing index factors of etiology, sex, age, primary or recurrent disease, TACE or TAI, and previous therapy.
Adverse events	Incidences of any adverse event were 67.3% (33/49) in the cisplatin group and 63.3% (31/49) in the miriplatin group (P=0.6712, Table 5). No major complications of grade 4 or higher occurred in either group. Grade 3 nausea occurred in 1 patient in the cisplatin group. Anaphylaxis occurred in 1 patient in each group, both during the second session. Both cases fulfilled all major criteria of the definition by Ruggeberg JU, et al 18 for the diagnosis of anaphylactic shock. The amount of drug at the first session was 100 mg of cisplatin and 75 mg of miriplatin. Each patient continued TACE with another agent. Diphasic fever appeared in 1 patient in the cisplatin group and in 5 patients in the miriplatin group (P=0.079). No other differences were found between the groups for each effect (Table 5).
Outcome measures	The primary endpoint was the TE 3 months after initial TACE or TAI, and the secondary endpoint was overall survival.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 04 Month 01 Day
Date of IRB	2010 Year 04 Month 23 Day
Anticipated trial start date	2010 Year 05 Month 01 Day
Last follow-up date	2015 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	2010 Year 04 Month 05 Day
Last modified on	2021 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004155