UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042750 |
|---|---|
| Receipt number | R000048792 |
| Scientific Title | Efficacy of Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma |
| Date of disclosure of the study information | 2020/12/21 |
| Last modified on | 2020/12/14 17:41:26 |
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Basic information
Public title
Efficacy of Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma
Acronym
Efficacy of Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma
Scientific Title
Efficacy of Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma
Scientific Title:Acronym
Efficacy of Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular Carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the therapeutic effect, OS and Adverse Events
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OS,PFS and TE(within3month by enhanced CT or enhanced MRI) based on RECIST1.1
Key secondary outcomes
safety:HFS,diarrhea,malaise,appitite loss,liver failuar,proteinuria,Tumor marker(AFP,DCP),Child-Pugh score
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1The diagnosis confirmed by histologic or cytologic analysis or clinical features.
2Diagnosed unresectable HCC.3More over 4week past since resection,RFA or TACE.4Child-Pugh score within 6point.5Performance status by ECOG 0~1.6Screening performed HB virus and HC virus.7Reserved Organ functionWBC:2,000/mm3,10,000/mm3Platelet:50,000/mm3
Hemoglobin:8.0 g/dlTotal Bilirubin:2.0 mg/dlPT:70%Creatinine:2 mg/dlAlbumin:2.8 g/dl
8All patients gave written informed consent.
Key exclusion criteria
1Untreated or incompletely treated esophageal or gastric varices.2With bleeding or high risk of bleeding.3Thromboembolic event.4Wounded.5Brain metastasis.6Uncontrolled Hypertension.
7Uncontrolled Ascites.
8History of autoimmune disease.
9Pulmonary fibrosis.
10Tuberculosis.
11Severe Hart failure.
12Long QT Syndrome.
13infection within 4weeks.
14Vaccination within 4weeks.
15Pregnant.
16Allergic.
17Un suitable Patient.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Takai |
Organization
Gifu university school of medicine
Division name
First Dept of internal medicine
Zip code
5011194
Address
yanagido1-1,gifu pref ,japan
TEL
058-230-6308
koz@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Takai |
Organization
Gifu university school of medicine
Division name
First Dept of internal medicine
Zip code
5011194
Address
yanagito1-1,gifu pref ,japan
TEL
0582306308
Homepage URL
koz@gifu-u.ac.jp
Sponsor or person
Institute
Gifu university first Dept of internalmedicine
Institute
Department
Personal name
Funding Source
Organization
Gifu university first Dept of internalmedicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
gifu university
Address
yanagito1-1,gifu pref ,japan
Tel
0582306308
koz@gifu-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-190
Org. issuing International ID_1
2020-190
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 12 | Month | 14 | Day |
Last modified on
| 2020 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048792
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| Registered date | File name |
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