UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013089 |
|---|---|
| Receipt number | R000012676 |
| Scientific Title | Maintenance Therapy of Sorafenib after Hepatic Resection for high risk recurrence hepatocellular carcinoma (MISORA) |
| Date of disclosure of the study information | 2014/02/06 |
| Last modified on | 2014/02/06 12:56:47 |
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Basic information
Public title
Maintenance Therapy of Sorafenib after Hepatic Resection for high risk recurrence hepatocellular carcinoma (MISORA)
Acronym
Sorafenib after Hepatic Resection for high risk recurrence HCC (MISORA)
Scientific Title
Maintenance Therapy of Sorafenib after Hepatic Resection for high risk recurrence hepatocellular carcinoma (MISORA)
Scientific Title:Acronym
Sorafenib after Hepatic Resection for high risk recurrence HCC (MISORA)
Region
| Japan |
Condition
Condition
Hepatocellular Carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and the safety of sorafenib after hepatectomy for high risk recurrence hepatocellular carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
PFS
Key secondary outcomes
TTP
OS
Safety
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 for 6 months
start at 2-8 W after resection
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 with hepatocellular carcinoma (HCC) histologically or clinically diagnosed
2. Patients after macroscopically curative resection for HCC with vascular invasion (Vv2-3), over 7 cm in diameter, or over 2 of tumor-to-nontumor ratio by FDG-PET
3. Patients with Child-Pugh score under 7 and performance status 0 or 1
4. Patients without complication of surgery (2-8 weeks after surgery)
5. adequate bone marrow function (neutrophil count ≥1,500/mm3, hemoglobin ≥7.5 g/dl, platelet count ≥50,000/mm3), liver function (total bilirubin < 1.5 mg/dL, aspartate aminotransferase [AST]/alanine aminotransferase [ALT] ≤200 IU/L, Albumin ≥3.0 g/dl)
6. Cooperative patients
7. Patients provided written informed consent
Key exclusion criteria
1. Previous history with sorafenib within 3 months before surgery
2. Allergy with sorafenib
3. age within the childbearing range for women
4. Severe complications
5. Patients with residual tumors
6. Other active malignancies
7. Severe renal disorders
8. Severe bronchial athma
9.severe heart disease; uncontrollable hypertension
10. Uncontrollable ascites
11. History of liver transplantaion
12. Uncontrollable esophageal varix
13. History of hepatic encephalopathy
14. Receiving medical therapy affecting sorafenib
15. Receiving herbal medicine
16. HIV-related disease
17. Patients inappropriate for study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Etsuro Hatano |
Organization
Kyoto University
Division name
Department of Surgery
Zip code
Address
54 kawaharacho Shogoin Sakyo-ku Kyoto
TEL
075-751-4323
esu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Seo |
Organization
Kyoto University
Division name
Department of Surgery
Zip code
Address
54 kawaharacho Shogoin Sakyo-ku Kyoto
TEL
075-751-4323
Homepage URL
rutosa@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Surgery, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
KHBO
Organization
Division
Category of Funding Organization
Self funding
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
YES
Study ID_1
KHBO1303
Org. issuing International ID_1
KHBO
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学 大阪大学 大阪市立大学
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 09 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 09 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 09 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 06 | Day |
Last modified on
| 2014 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012676
