UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008571 |
|---|---|
| Receipt number | 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 19:00:22 |
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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
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
ishizakm@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Hirakata Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009793
