UMIN-CTR Clinical Trial

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
Email	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
Email	koz@gifu-u.ac.jp

Sponsor
Institute	Gifu university first Dept of internalmedicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048792