UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026648 |
|---|---|
| Receipt number | R000030240 |
| Scientific Title | Adjuvant Treatment with nivolumab in the Prevention of recurrence after curative treatment of Hepatocellular Carcinoma(NIVOLVE) |
| Date of disclosure of the study information | 2017/03/23 |
| Last modified on | 2023/03/09 14:22:22 |
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Basic information
Public title
Adjuvant Treatment with nivolumab in the Prevention of recurrence after curative treatment of Hepatocellular Carcinoma(NIVOLVE)
Acronym
NIVOLVE
Scientific Title
Adjuvant Treatment with nivolumab in the Prevention of recurrence after curative treatment of Hepatocellular Carcinoma(NIVOLVE)
Scientific Title:Acronym
NIVOLVE
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 investigate the efficacy of nivolumab in the adjuvant treatment after curative therapy for hepatocellular carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
1-year recurrence free survival rate
Key secondary outcomes
Reccurence free survival
2-year recurrence free survival rate
Overall survival
Tumor markers
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
Nivolumab is administered intravenously
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.Initially diagnosed hepatocellular carcinoma with histological or radiological confirmation.
2.Intermediate or High Risk of recurrence as assessed by tumor characteristics.
3.Child-Pugh A
4.ECOG Performance Status of 0.
5.Adequate bone marrow, liver and renal function
6.Written informed concent
Key exclusion criteria
1.History of treatment except for hepatic resection of RFA
2.History or present of autoimmune disease
3.History or present of inestitial neumonia
4.History of malignancy
5.Renal falure
6.severe heart disease
7.severe hypertension
8.active infection
9.History of treatment using immunotherapy such as immune checkpoint inhibitor, peptide vaccine, biochemical modulator and Lymphocyte stimulation therapy
10.pregnancy or breast feeding
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoshi Kudo |
Organization
Kindai University Faculty of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
377-2, Oono-Higashi, Osaka-Sayama, Osaka, Japan
TEL
072-366-0221
m-kudo@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuomi Ueshima |
Organization
Kindai University Faculty of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
377-2, Oono-Higashi, Osaka-Sayama, Osaka, Japan
TEL
072-366-0221
Homepage URL
kaz-ues@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Faculty of Medicine
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 07 | Month | 02 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 22 | Day |
Last modified on
| 2023 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030240
