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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013089
Receipt No. 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

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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 &#8805;1,500/mm3, hemoglobin &#8805;7.5 g/dl, platelet count &#8805;50,000/mm3), liver function (total bilirubin < 1.5 mg/dL, aspartate aminotransferase [AST]/alanine aminotransferase [ALT] &#8804;200 IU/L, Albumin &#8805;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
Email 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
Email rutosa@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Surgery, Kyoto University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012676

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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