UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048296 |
|---|---|
| Receipt number | R000054917 |
| Scientific Title | Phase II clinical trial to evaluate the safety and efficacy of particle radiotherapy preceded atezolizumab plus bevacizumab treatment in patients with unresectable multiple hepatocellular carcinoma |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2023/07/07 09:07:07 |
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Basic information
Public title
Phase II clinical trial to evaluate the safety and efficacy of particle radiotherapy preceded atezolizumab plus bevacizumab treatment in patients with unresectable multiple hepatocellular carcinoma
Acronym
Phase II clinical trial to evaluate the safety and efficacy of particle radiotherapy preceded atezolizumab plus bevacizumab treatment in patients with unresectable multiple hepatocellular carcinoma
Scientific Title
Phase II clinical trial to evaluate the safety and efficacy of particle radiotherapy preceded atezolizumab plus bevacizumab treatment in patients with unresectable multiple hepatocellular carcinoma
Scientific Title:Acronym
Phase II clinical trial to evaluate the safety and efficacy of particle radiotherapy preceded atezolizumab plus bevacizumab treatment in patients with unresectable multiple hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of particle radiotherapy and atezolizumab plus bevacizumab treatment for unresectable multiple hepatocellular carcinomas in a phase II study.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Adverse event rate
Tumor size reduction rate (irradiated and non-irradiated lesions)
Objective response rate (RECIST)
Overall survival (OS)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Atezolizumab plus bevacizumab treatment
Particle 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. 18 years of age or older at the time of consent
2. PS 0 or 1
3.Child-Pugh Classification A
4. No more than moderate ascites and no
hepatic encephalopathy
5. Hepatocellular carcinoma diagnosed by
imaging or histology
6. Diagnosed as unresectable and the main
lesion is greater than 4 cm in length
7. Intrahepatic lesions meet one of the
following
a. not meeting Up-to-7 criteria
b. portal vein tumor thrombus (Vp2-4)
and/or inferior vena cava tumor
thrombus(Vv2, 3)
8. Multiple intrahepatic lesions which
delivering curative irradiation of
particle therapy deemed impossible.
9. No extrahepatic metastases
10. Patients who have been fully informed
of the details of this study and have
given their free and voluntary written
consent.
Key exclusion criteria
1. Patients with multiple cancers.
Patients with multiple cancers, but no
signs of recurrence for at least 5
years after completion of treatment,
and patients with epithelial cancer or
endoscopically resectable
gastrointestinal cancer within 5 years
of completion of treatment may be
enrolled.
2.Patients with untreated or poorly
treated esophageal and/or gastric
varices with or at high risk of
bleeding. Patients who have undergone
esophagogastroduodenoscopy prior
to enrollment and who have been
evaluated and treated for all varices,
large or small, according to the
institution's standard of care, and who
are judged to have a low risk of
bleeding may be enrolled.
3. Patients who are judged to be
inappropriate to participate in this
study by the principal investigator or
sub-investigator.
4. Patients who are judged to be
inappropriate according to the latest
practice guideline for the use of
atezolizumab/bevacizumab combination
therapy.
5. Other patients deemed inappropriate
by the study investigators
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Fukumoto |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
0783826302
fukumoto@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Komatsu |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
0783826302
Homepage URL
komasho8@gmail.com
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe 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
Kobe University Graduate School of Medicine
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel
0783826302
komasho8@gmail.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
| 2022 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054917
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