UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008689 |
|---|---|
| Receipt number | R000008809 |
| Scientific Title | A clinical study on safety and efficacy of sorafenib as maintenance chemotherapy after percutaneous isolated hepatic perfusion chemotherapy (PIHP) for advanced hepatocellular carcinoma |
| Date of disclosure of the study information | 2012/09/19 |
| Last modified on | 2018/02/17 21:21:32 |
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Basic information
Public title
A clinical study on safety and efficacy of sorafenib as maintenance chemotherapy after percutaneous isolated hepatic perfusion chemotherapy (PIHP) for advanced hepatocellular carcinoma
Acronym
A safety and efficacy of sorafenib as maintenance chemotherapy after percutaneous isolated hepatic perfusion (PIHP) for advanced hepatocellular carcinoma
Scientific Title
A clinical study on safety and efficacy of sorafenib as maintenance chemotherapy after percutaneous isolated hepatic perfusion chemotherapy (PIHP) for advanced hepatocellular carcinoma
Scientific Title:Acronym
A safety and efficacy of sorafenib as maintenance chemotherapy after percutaneous isolated hepatic perfusion (PIHP) for advanced hepatocellular carcinoma
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyze the safety and efficacy of sorafenib as maintenance therapy after percutaneous isolated hepatic perfusion (PIHP) for advanced hepatocellular carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
One year overall survival
Key secondary outcomes
Progression or recurrence free survival
Overall survival
Safety of sorafenib administration after PIHP
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
After 4-8 weeks of PIHP, sorafenib therapy starts with a primary dose of 800mg/day. Sorafenib therapy continues until the appearance of unacceptable side effect or tumor progression.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who underwent PIHP for advanced hepatocellular carcinoma
2)Patients who were diagnosed as hepatocellular carcinoma radiologically or pathologically
3)Patients who have no indication of surgical resection, local therapy (RFA, TACE, percutaneous ethanol injection)
4)Patients who satisfy the criteria of sorafenib administration
5)Patients who approve sorafenib therapy and sign a document for it.
Key exclusion criteria
1)Patients with a history of molecular- target therapy including sorafenib.
2)Patients with a history of hypersensitivity of sorafenib
3)Patients who are pregnant or on nurse.
4)Patients who are on dialysis
5)Patients with uncontrolled hypertension
6)Patients with a history of thrombosis, embolism, or ischemic Heart Disease
7)Patients with brain metastasis
8)Patients with esophageal varix with bleeding tendency
9)Patients with gastrointestinal bleeding within one month
10)Patients with ongoing or history of hepatic encephalopathy
11)Patients who undergo rifampin
12)Patients with HIV or AIDS
13)Patients with synclonous double cancer
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fukumoto Takumi |
Organization
Kobe University
Division name
Department of hepato-biliary-pancreatic surgery
Zip code
Address
7-5-2, Kusunokicho, Chuo-Ku, Kobe, Japan
TEL
078-382-6302
fukumoto@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motofumi Tanaka |
Organization
Kobe University
Division name
Department of hepato-biliary-pancreatic surgery
Zip code
Address
7-5-2, Kusunokicho, Chuo-Ku, Kobe, Japan
TEL
078-382-6302
Homepage URL
motofutanaka-gi@umin.net
Sponsor or person
Institute
Department of hepato-biliary-pancreatic surgery, Kobe University
Institute
Department
Personal name
Funding Source
Organization
Bayer Pharma
Organization
Division
Category of Funding Organization
Profit organization
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
Kobe University Graduate School of Medicine
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 19 | 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 | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 01 | Month | 19 | Day |
Date analysis concluded
| 2017 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 15 | Day |
Last modified on
| 2018 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008809
