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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000047758
Receipt No. R000054447
Scientific Title Multicenter study for biomarker on therapeutic effect and safety of Atezolizumab + Bevacizumab in patients with unresectable hepatocellular carcinoma
Date of disclosure of the study information 2022/05/16
Last modified on 2022/05/16

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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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