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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008571
Receipt No. R000009793
Scientific Title Phase II study of weekly fractionated hepatic arterial infusion of Sorafenib and Cisplatin for advanced hepatocellular carcinoma.
Date of disclosure of the study information 2012/07/31
Last modified on 2021/02/04

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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/ctr_e/ctr_view.cgi?recptno=R000009793

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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