UMIN-CTR Clinical Trial

Basic information
Public title	Randomized phase II study exploring better regimen of hepatic arterial infusion chemotherapy for the patients with advanced hepatocellular carcinoma
Acronym	Randomized phase II study exploring better regimen of hepatic arterial infusion chemotherapy for the patients with advanced hepatocellular carcinoma
Scientific Title	Randomized phase II study exploring better regimen of hepatic arterial infusion chemotherapy for the patients with advanced hepatocellular carcinoma
Scientific Title:Acronym	Randomized phase II study exploring better regimen of hepatic arterial infusion chemotherapy for the patients with advanced hepatocellular carcinoma
Region	Japan

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

Objectives
Narrative objectives1	To compare the efficacy of hepatic arterial infusion chemotherapy for advanced hepatocellular carcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression-free survival
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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	HAIC using FP regimen
Interventions/Control_2	HAIC using CDDP regimen
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	clinically diagnosed as hepatocellular carcinoma; presence of intrahepatic lesion; unsuitable for local therapy; unsuitable for standard therapy including sorafenib; Child-Pugh score <=8; ECOG Performance status <=2; preservation of major organ function; written informed consent
Key exclusion criteria	technically unsuitable for HAIC; extrahepatic lesion; refractory ascites or pleural effusion, history of hepatic encephalopathy, risky varices; double cancer; metastases to central nervous system; severe complication; pregnant or lactating women, or women of childbearing potential; mental disorder; allergy for fluorouracil, cisplatin, or contrast agent of CT or/and MRI
Target sample size	125

Research contact person
Name of lead principal investigator	1st name Shuichi Middle name Last name Kaneko
Organization	Kanazawa University Hospital
Division name	Department of Gastroenterology
Zip code	920-8641
Address	13-1, Takaramachi, Kanazawa
TEL	076-265-2235
Email	skaneko@m-kanazawa.jp

Public contact
Name of contact person	1st name Tatsuya Middle name Last name Yamashita
Organization	Kanazawa University Hospital
Division name	Department of Gastroenterology
Zip code	920-8641
Address	13-1, Takaramachi, Kanazawa
TEL	076-265-2235
Homepage URL
Email	ytatsuya@m-kanazawa.jp

Sponsor
Institute	Kanazawa University Hospital
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	Certified Review Board, Kanazawa University
Address	13-1, Takaramachi, Kanazawa
Tel	076-265-2048
Email	hpsangak@adm.kanazawa-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	2016 Year 03 Month 16 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	2016 Year 03 Month 15 Day
Date of IRB	2016 Year 02 Month 24 Day
Anticipated trial start date	2016 Year 03 Month 16 Day
Last follow-up date	2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 03 Month 15 Day
Last modified on	2019 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024750