UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034931 |
|---|---|
| Receipt number | R000039709 |
| Scientific Title | PhaseII study of Nivolumab monotherapy for patients with occupational cholangiocarcinoma |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2023/11/24 06:37:55 |
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Basic information
Public title
PhaseII study of Nivolumab monotherapy for patients with occupational cholangiocarcinoma
Acronym
OPAL study
Scientific Title
PhaseII study of Nivolumab monotherapy for patients with occupational cholangiocarcinoma
Scientific Title:Acronym
OPAL study
Region
| Japan |
Condition
Condition
Occupational-related unresectable or recurrent cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate efficacy and safety of Nivolumab monotherapy in Occupational-related unresectable or recurrent cholangiocarcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Objective response rate
Key secondary outcomes
Incidences of adverse events
Decrease rate of CA19-9
Disease control rate
Progression-free survival
Overall survival
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(480mg/body) is administered.
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)Has diagnosed cholangiocarcinoma by histology or cytology. But, organization type isn't limited.
(2)Has unresectable or recurrent cholangiocarcinoma that are refractory or intolerant to a regimen containing gemcitabine, or have refused these treatments.
(3)Has occupational-related cholangiocarcinoma caused by organic solvents such as 1,2 dichloropropane and dichloromethane used in the printing business etc.
(4)Age 20 years or above
(5)Has one or more evaluable lesions as defined in RECIST version 1.1.
(6)ECOG Performance Status of 0-2
(7)Has adequate organ function at the registration.
(8)Agreed to contracept for a certain period.
Key exclusion criteria
(1)Has merger or past history of autoimmune diseases.
(2)Has duplicate cancer.
(3)Has metastatic lesions in the brain or meningeal membrane.
(4)Has serious complications (intestinal obstruction, interstitial lung disease, diabetes etc.)
(5)Has pleural or ascites, that require treatment.
(6)Has poor pain control.
(7)Has received antibody therapy or medication therapy in the past.
(8)Has remain strongly influenced by side effects due to pretreatment or surgery.
(9)Has history of serious heart disease or one with the findings.
(10)Has systemic infections that require treatment.
(11)Isn't pregnant or breast-feeding.
(12)Judged to be in a state lacking consent ability due to merger of dementia.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Ikeda |
Organization
National Cancer Center Hospital East
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
277-8577
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
TEL
04-7133-1111
Opal_core@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Umemoto |
Organization
St.Marianna University School of Medicine Hospital
Division name
Department of Medical Oncology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, 216-8511, Japan
TEL
044-977-8111
Homepage URL
Opal_core@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Ono pharmaceutical co.,ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital Institutional Review Board
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
Tel
04-7133-1111
irboffice@east.ncc.go.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
国立研究開発法人 国立がん研究センター東病院（千葉県）
大阪市立大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 01 | 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
6
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
| 2018 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | 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 | 11 | Month | 19 | Day |
Last modified on
| 2023 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039709
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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