UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of weekly fractionated hepatic arterial infusion of Sorafenib and Cisplatin for advanced hepatocellular carcinoma.
Acronym	Phase II study of weekly fractionated hepatic arterial infusion of Sorafenib and CDDP for advanced
Scientific Title	Phase II study of weekly fractionated hepatic arterial infusion of Sorafenib and Cisplatin for advanced hepatocellular carcinoma.
Scientific Title:Acronym	Phase II study of weekly fractionated hepatic arterial infusion of Sorafenib and CDDP for advanced
Region	Japan

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

Objectives
Narrative objectives1	This study aimed to evaluate the efficacy of Sorafenib and hepatic arterial infusion with Cisplatin for advanced hepatocellular carcinoma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Progression free survival, Overall survival, Adverse event rate

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	This study aimed to evaluate the efficacy of Sorafenib and hepatic arterial infusion with Cisplatin for advanced hepatocellular carcinoma.
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Patients diagnosed with HCC 2.Above vp3 3.Child-Pugh A or B 4.ASA PS 0-1 5.WBC>3000/ul, Neutro>1500/ul, Hb>10.0g/dl, Platelet>75000/ul, T-Bil below 1.5 times higher than normal range, AST/ALT below 5 times higher than normal range, Creatinine below 1.5 times higher than normal range. 6.Beyond surgical indication 7.Patients that agree this study on document of informed concent
Key exclusion criteria	1.Presence of metastasis 2.Presence of hepatic encephalopathy 3.Patients with active bacterial infection 4.Patients having blood vessel abnormality that difficult to insert hepatic arterial infusion port 5.Patients having severe disease 6.Patients losing of control over bowel movements 7.Patients with double cance 8.During pregnancy or breast-feeding woman 9.Contraindication of sorafenib or cisplatin
Target sample size	33

Research contact person
Name of lead principal investigator	1st name Middle name Last name Morihiko Ishizaki
Organization	Kansai Medical University Hirakata Hospital
Division name	Department of surgery
Zip code
Address	2-3-1 Shinmachi, Hirakata Osaka 573-1191 JAPAN
TEL	072-804-0101
Email	ishizakm@hirakata.kmu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Morihiko Ishizaki
Organization	Kansai Medical University Hirakata Hospital
Division name	Department of surgery
Zip code
Address	2-3-1 Shinmachi, Hirakata Osaka 573-1191 JAPAN
TEL	072-804-0101
Homepage URL
Email	ishizakm@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Hirakata Hospital
Institute
Department

Funding Source
Organization	Kansai Medical University Hirakata Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	none
Name of secondary funder(s)	none

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	関西医科大学附属枚方病院

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 31 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	2012 Year 05 Month 01 Day
Date of IRB	2012 Year 07 Month 01 Day
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date	2020 Year 08 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	2012 Year 07 Month 30 Day
Last modified on	2021 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009793