UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004107 |
|---|---|
| Receipt number | 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 10:53:08 |
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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
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
ishizakm@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Hirakata Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004941
