UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051549 |
|---|---|
| Receipt number | R000058805 |
| Scientific Title | Prospective interventional clinical study to evaluate the efficacy and safety of atezolizumab plus bevacizumab in combination with carbon ion radiotherapy for unresectable hepatocellular carcinoma |
| Date of disclosure of the study information | 2023/07/07 |
| Last modified on | 2024/01/06 09:53:52 |
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Basic information
Public title
Prospective interventional clinical study to evaluate the efficacy and safety of atezolizumab plus bevacizumab in combination with carbon ion radiotherapy for unresectable hepatocellular carcinoma
Acronym
Efficacy Study of Atezolizumab + Bevacizumab Therapy in Combination with carbon ion radiotherapy
Scientific Title
Prospective interventional clinical study to evaluate the efficacy and safety of atezolizumab plus bevacizumab in combination with carbon ion radiotherapy for unresectable hepatocellular carcinoma
Scientific Title:Acronym
Prospective interventional clinical study to evaluate the efficacy and safety of atezolizumab plus bevacizumab in combination with carbon ion radiotherapy for 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
The objective of this study is to evaluate the efficacy and safety of the combination of carbon ion radiotherapy and atezolizumab/bevacizumab in prolonging overall survival (OS) and progression-free survival (PSF) in patients with unresectable hepatocellular carcinoma, compared with the efficacy of carbon ion radiotherapy alone.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Over survival+Progression-free survival for carbon ion radioherapy and Atezolizumab/Bevacizumab Combination Therapy
Key secondary outcomes
Objective response rate and Incidence of side effects
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Atezolizumab plus bevacizumab with carbon ion radiotherapy
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
Age at which consent was obtained is 20 years or older
Patients with unresectable hepatocellular carcinoma
Child-Pugh classification: Class A
Patients who are scheduled to receive atezolizumab/bevacizumab combination therapy in clinical practice based on the latest package insert and guidelines for promoting optimal use.
Patients who received atezolizumab/bevacizumab combination therapy prior to the heavy ion therapy will be eligible for enrollment.
Patients who have been fully informed of the details of the study and who have given their free and voluntary written consent.
Key exclusion criteria
Patients with untreated or poorly treated esophageal aneurysms and/or gastric varices with or judged to be at high risk for bleeding.
Patients who have undergone esophagogastroduodenoscopy (EGD) prior to enrollment, have been examined and treated for varices, and have been determined to be at low risk for bleeding will be eligible for enrollment. (EGD will not be required if performed within 6 months prior to starting atezolizumab/bevacizumab combination therapy.)
Patients who are deemed inappropriate by the principal investigator or study investigators to participate in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Katsumi |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Gastroenterology
Zip code
990-9585
Address
2-2-2 Iidanishi Yamagata-city Yamagata, Japan
TEL
023-628-5309
t-katsumi@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Katsumi |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Gastroenterology
Zip code
990-9585
Address
2-2-2 Iidanishi Yamagata-city Yamagata, Japan
TEL
023-628-5309
Homepage URL
t-katsumi@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University
Institute
Department
Personal name
Funding Source
Organization
Yamagata University
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
Yamagata University Faculty of Medicine
Address
2-2-2 Iidanishi Yamagata-city Yamagata, Japan
Tel
023-628-5309
t-katsumi@med.id.yamagata-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
| 2023 | Year | 07 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 07 | Day |
Last modified on
| 2024 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058805
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| Registered date | File name |
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