UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045131 |
|---|---|
| Receipt number | R000050953 |
| Scientific Title | Comprehensive analysis of cytokines and PD-L1 before and after administration of Atezolizumab and Bevasizumab in patients with HCC |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2022/02/11 11:10:02 |
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Basic information
Public title
Comprehensive analysis of cytokines and PD-L1 before and after administration of Atezolizumab and Bevasizumab in patients with HCC
Acronym
ASTRAL-HCC
Scientific Title
Comprehensive analysis of cytokines and PD-L1 before and after administration of Atezolizumab and Bevasizumab in patients with HCC
Scientific Title:Acronym
ASTRAL-HCC
Region
| Japan |
Condition
Condition
Hapatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analysis of the biomarkers for atezolizumab and bevasizumab in patients with HCC
Basic objectives2
Others
Basic objectives -Others
Exploration of biomarkers
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum cytokine, PD-L1, PD-1, CTLA-4
Key secondary outcomes
Overall Response Rat, Time to treatment failure, Progression-free survival, Overall survival, Adverse event, immune-related Adverse Events (irAE), Steroid use for irAE management, Liver functional
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Over age 20
(2) Unresectable hepatocellular carcinoma
(3) Child-Pugh class A
(4) Current or prior use of sorafenib or lenvatinib
(5) No implementation of transarterial chemoembolization within 60 days
(6) Satisfied Indication of the package insert according of ATZ/BV
(7) Approved informed consent
Key exclusion criteria
(1) Current use of anticoagulants or antiplatelets or prior use within 10 days
(2) High risk of bleeding or untreated/incompletely treated esophageal/gastric varix
(3) Thrombosis or embolism within 180 days
(4) Major surgery within 28 days
(5) Use of immunostimulants within 180 days
(6) Use of immunosuppressants within 14 days
(7) Autoimmune disease within 180 days
(8) Double cancer or prior malignant neoplasm except early malignancy
(9) Enrollment to an intervention study or a study using unapproved drug
(10) Severe cardiovascular disease, unstable arrhythmia, unstable angina within 90 days
(11) Pregnancy, breastfeeding, no approve for contraception
(12) Uncontrollable pleural effusion, pericardial fluid, or ascites
(13) Hepatic encephalopathy
(14) Uncontrollable hypertension, severe infection, hemodialysis
(15) Allergy or anaphylactic reaction to chimeric antibody, humanized antibody, or fusion protein
(16) Allergy to atezolizumab and bevasizumab
(17) Current or prior active hemorrhagic disease
(18) Oral feeding difficulty
(19) HIV positivity
(20) Active pulmonary fibrosis or interstitial pneumonia
(21) Blood transfusion or G-CSF within 14 days
(22) Unsuitable patient at a physician's decision
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kyoji |
| Middle name | |
| Last name | Ito |
Organization
National Center for Global Health and Medicine
Division name
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
162-8655
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
kyito@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Kyoji |
| Middle name | |
| Last name | Ito |
Organization
National Center for Global Health and Medicine
Division name
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
162-8655
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
kyito@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
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
National Center for Global Health and Medicine Ethical Review Board
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
Tel
03-3202-7181
ncgm@esct.bvits.com
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
| 2021 | Year | 09 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | 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
Cytokines were measured before and after administration of atezolizumab and bevasizumab in patients with HCC. The association between the measured cytokines and clinical outcomes (overall response rate, time to treatment failure, progression-free survival, and adverse event) is analyzed.
Management information
Registered date
| 2021 | Year | 08 | Month | 12 | Day |
Last modified on
| 2022 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050953
