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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004107
Receipt No. R000004941
Scientific Title The effect of Sorafenib and intermittent hepatic arterial infusion chemotherapy using Cisplatin for advanced hepatocellular carcinoma with portal vein tumor thrombus : a phase 1 study
Date of disclosure of the study information 2010/09/01
Last modified on 2016/06/22

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Basic information
Public title The effect of Sorafenib and intermittent hepatic arterial infusion chemotherapy using Cisplatin for advanced hepatocellular carcinoma with portal vein tumor thrombus : a phase 1 study
Acronym The effect of Sorafenib and intermittent HAIC using CDDP for advanced HCC with PVTT : P-1 study
Scientific Title The effect of Sorafenib and intermittent hepatic arterial infusion chemotherapy using Cisplatin for advanced hepatocellular carcinoma with portal vein tumor thrombus : a phase 1 study
Scientific Title:Acronym The effect of Sorafenib and intermittent HAIC using CDDP for advanced HCC with PVTT : P-1 study
Region
Japan

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

Objectives
Narrative objectives1 We evaluate the safety and efficacy of this therapy for advanced HCC
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Dose limiting toxicity, Recommended dose
Key secondary outcomes Adverse event rate, Response 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 sorafenib:400mg (oral intake) for 28 days
CDDP:20mg/m2 HAIC (day1,8,15)
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
85 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 18

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

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 Kansai Medical University Hirakata Hospital
TEL 072-804-0101
Homepage URL
Email ishizakm@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University Hirakata Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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
2010 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 Completed
Date of protocol fixation
2010 Year 03 Month 12 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 26 Day
Last modified on
2016 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=R000004941

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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