UMIN-CTR Clinical Trial

Basic information
Public title	Study on biomarkers for the effect and safety of the treatment with Atezolizumab + Bevacizumab for liver cancer
Acronym	Study on biomarkers for liver cancer
Scientific Title	Multicenter study for biomarker on therapeutic effect and safety of Atezolizumab + Bevacizumab in patients with unresectable hepatocellular carcinoma
Scientific Title:Acronym	Study on biomarkers in treatment with Atezolizumab + Bevacizumab for hepatocellular carcinoma
Region	Japan

Condition
Condition	unresectable advanced hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In this study, we will focus on the presence or absence of fever that appears early after the administration of Atezolizumab + Bevacizumab in patients with unresectable advanced hepatocellular carcinoma. By examining the changes in blood cytokines and chemokines by the fever after the treatment, we will search for biomarkers related to early treatment efficacy and the development of irAEs, aiming to establish a suitable strategy with Atezolizumab + Bevacizumab treatment for advanced hepatocellular carcinoma.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Investigating the biomarkers, including cytokine and chemokine at pretreatment, 1,3,6 week after treatment, on adverse events, including immune-related liver injury
Key secondary outcomes	Investigating the biomarkers, including cytokine and chemokine at pretreatment, 1,3,6 week after treatment, on the therapeutic effects and prognosis

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	Clinically diagnosed as HCC No indication for local treatment such as liver resection, liver transplantation, or radiofrequency ablation Having a treatable liver function Performance status of 0-2 on ECOG Age is 20 years or older.
Key exclusion criteria	Patients who wish to be excluded from the study. Patients who are pregnant, or lactating, may become pregnant, intend to become pregnant, or who wish to have a baby. Patients with the following serious complications: 1. Cardiovascular abnormalities such as heart failure, angina pectoris, or arrhythmia are difficult to control even after treatment. 2. Myocardial infarction within 6 months of onset 3. Renal failure 4. Active infectious disease except for viral hepatitis 5. Active gastrointestinal bleeding 6. Other active cancer requiring treatment 7. Hepatic encephalopathy or severe mental disorder 8. Severe drug allergy 9. Serious autoimmune disease. Other conditions that the physician deems inappropriate for the safe conduct of this study.
Target sample size	91

Research contact person
Name of lead principal investigator	1st name Masatoshi Middle name Last name Ishigami
Organization	Nagoya University Graduate School of Medicine
Division name	Gastroenterology and Hepatology
Zip code	466-8560
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560, Japan.
TEL	0527442169
Email	masaishi@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Takanori Middle name Last name Ito
Organization	Nagoya University Hospital
Division name	Gastroenterology and Hepatology
Zip code	466-8560
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560, Japan.
TEL	0527442169
Homepage URL
Email	tahkun56@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Ogaki Municipal Hospital Kariya Toyota general hospital Tosei General Hospital Toyohashi Municipal Hospital Fujita Health University National Center for Global Health and Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya University Graduate School of Medicine
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560, Japan.
Tel	0527442423
Email	tahkun56@med.nagoya-u.ac.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

Other administrative information
Date of disclosure of the study information	2022 Year 05 Month 16 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	2022 Year 05 Month 06 Day
Date of IRB	2022 Year 03 Month 24 Day
Anticipated trial start date	2022 Year 05 Month 06 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	not applicable

Management information
Registered date	2022 Year 05 Month 14 Day
Last modified on	2022 Year 05 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054447

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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