UMIN-CTR Clinical Trial

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
Email	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
Email	kyito@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050953