UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030718 |
|---|---|
| Receipt number | R000035059 |
| Scientific Title | Combination of molecularly-targeted therapy with stereotactic body radiotherapy in hepatocellular carcinoma with major vascular invasion |
| Date of disclosure of the study information | 2018/01/09 |
| Last modified on | 2021/01/09 14:04:03 |
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Basic information
Public title
Combination of molecularly-targeted therapy with stereotactic body radiotherapy in hepatocellular carcinoma with major vascular invasion
Acronym
Combination of molecularly-targeted therapy with SBRT in HCC with MVI
Scientific Title
Combination of molecularly-targeted therapy with stereotactic body radiotherapy in hepatocellular carcinoma with major vascular invasion
Scientific Title:Acronym
Combination of molecularly-targeted therapy with SBRT in HCC with MVI
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma with major vascular invasion
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the safety and efficacy of the novel combination therapy of molecularly-targeted therapy with SBRT in patients having HCC with MVI.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety; occurrence rate of adverse events, occurrence rate of adverse events of grade 3 or more.
Key secondary outcomes
Efficacy; overall survival rate, progression-free survival, response rate, disease control 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 | Other |
Interventions/Control_1
1) Stereotactic body radiotherapy, 48Gy/4Fr toward the portion of vascular invasion of the tumor.
2) Seven to 28 days after radiotherapy, the molecularly-targeted agent is started.
The sorts of molecularly-targeted agents, that can be selected for this study, are sorafenib (at a dose of 800 mg daily), regorafenib (at a dose of 160 mg daily for the first 3 weeks of each 4-week cycle) or lenvatinib (at a dose of 120 mg daily in patients of body weight of 60 kg or more, or 80 mg daily in patients of body weight of less than 60 kg). The treatment interruption and dose reduction are allowed to manage drug toxicity.
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
The eligible subject must;
1) Be able to provide written informed consent from the subject person.
2) Have no previous molecularly-targeted therapies or systemic chemotherapies.
3) Have an ECOG-PS 0 or 1.
4) Have the liver function of a Child-Pugh class A (5-6 points), or Child-Pugh score 7 points with serum albumin of 3.0-3.5 g/dl and prothrombin time of 60-70%.
5) Fulfill the following the values of laboratory testings within 14 days prior to the trial registration.
Neutrophils > 1500/mm^3, Hemoglobin > 8.5 g/dl, Platelets > 60000/mm^3, AST < x5 ULN, ALT < x5 ULN, Serum creatinine < 1.3 mg/dl, Creatinine clearance < 60 ml/min.
6) Received no treatments for HCC within 28 days prior to the trial registration.
7) Have a predicted life expentancy of 8 weeks or more.
Key exclusion criteria
The subject must be excluded if the subject;
1) Has the hepatic encephalopathy
2) Has the uncontrollable hypertension, heart failure, ischemic heart disease or arrhythmia.
3) Has had the acute myocardial infarction in the last 6 months.
4) Has the synchronous malignancies of other organs, or has had the metachronous ones in the last 2 years.
5) Has the serious psychiatric disorder or a serious decline in cognitive function.
6) Is pregnant or breastfeeding, or a female expecting to conceive a child.
7) Is judged to be inappropriate for the entry of this trial in the opinion of the treating investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Ohkawa |
Organization
Osaka International Cancer Institute
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
5418567
Address
3-1-69, Otemae, Chuo-ku, Osaka, Japan
TEL
81-6-6945-1181
kazuyoshi.ohkawa@oici.jp
Public contact
Name of contact person
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Ohkawa |
Organization
Osaka International Cancer Institute
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
5418567
Address
3-1-69, Otemae, Chuo-ku, Osaka, Japan
TEL
81-6-6945-1181
Homepage URL
kazuyoshi.ohkawa@oici.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Osaka International Cancer Institute
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
Osaka International Cancer Institute
Address
3-1-69, Otemae, Chuo-ku, Osaka, Japan
Tel
0669451181
kazuyoshi.ohkawa@oici.jp
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
| 2018 | Year | 01 | Month | 09 | 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
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2018 | Year | 01 | Month | 07 | Day |
Last modified on
| 2021 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035059
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| Registered date | File name |
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| Registered date | File name |
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