Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595108
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
ATezolizumab and BEvacizumab With STereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Atezolizumab and Bevacizumab With Stereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATBEST
Brief Summary:
To determine the efficacy and safety of atezolizumab-bevacizumab combination therapy plus stereotactic body radiotherapySBRT in patients with advanced hepatocellular carcinoma Subjects will start SBRT for one or more primary cancers andor metastatic lesions and no more than 5 sites within two month before and after the start date of atezolizumab-bevacizumab combination therapy
In this study it is expected to improve the treatment response rate of atezolizumab-bevacizumab therapy which is currently first-line chemotherapy but has a low treatment response rate
In this study it is expected to improve the treatment response rate of atezolizumab-bevacizumab therapy which is currently first-line chemotherapy but has a low treatment response rate
Detailed Description:
The subjects with advanced hepatocellular carcinoma who are indicated for the first-line atezolizumab-bevacizumab combination therapy are the primary subjects and if they voluntarily agree to the clinical trial after explanation of the clinical trial they are included in the clinical trial Subjects should begin SBRTstereotactic body radiotherapy to one or more but not more than five sites for primary cancer andor metastatic lesions within two month before and after the start date of atezolizumab-bevacizumab combination therapy
The followings are evaluation items for each visit
Visit 1 -60 weeks 7days Screening
Informed consent form
Inclusion Criteria Exclusion Criteria
Medical history and physical examination
Staging via CT MRI PET-CT etc PET-CT examination is not compulsory
CBC SMA PTaPTT Tumor markers Biomarkers
Stool microbiota NGS
QoL QuestionnaireEORTC-QLQ-C30 V3
Visit 2 07 weeks 7 days During SBRT
Confirmation of adverse events
QoL QuestionnaireEORTC-QLQ-C30 V3
Visit 3 18 weeks 1 week after SBRT
Confirmation of adverse events
CBC SMA PTaPTT Tumor markers Biomarkers
QoL QuestionnaireEORTC-QLQ-C30 V3
Visit 4 69 weeks 7 days After 2 cycles of chemotherapy
Confirmation of adverse events
CBC SMA PTaPTT Tumor markers Biomarkers
Stool microbiota NGS
QoL QuestionnaireEORTC-QLQ-C30 V3
Visit 512 336 months 2 weeks Follow-up
Confirmation of adverse events
Evaluation of effectiveness Imaging tests Tumor markers CBC SMA PTaPTT are performed according to the need
QoL QuestionnaireEORTC-QLQ-C30 V3
The followings are evaluation items for each visit
Visit 1 -60 weeks 7days Screening
Informed consent form
Inclusion Criteria Exclusion Criteria
Medical history and physical examination
Staging via CT MRI PET-CT etc PET-CT examination is not compulsory
CBC SMA PTaPTT Tumor markers Biomarkers
Stool microbiota NGS
QoL QuestionnaireEORTC-QLQ-C30 V3
Visit 2 07 weeks 7 days During SBRT
Confirmation of adverse events
QoL QuestionnaireEORTC-QLQ-C30 V3
Visit 3 18 weeks 1 week after SBRT
Confirmation of adverse events
CBC SMA PTaPTT Tumor markers Biomarkers
QoL QuestionnaireEORTC-QLQ-C30 V3
Visit 4 69 weeks 7 days After 2 cycles of chemotherapy
Confirmation of adverse events
CBC SMA PTaPTT Tumor markers Biomarkers
Stool microbiota NGS
QoL QuestionnaireEORTC-QLQ-C30 V3
Visit 512 336 months 2 weeks Follow-up
Confirmation of adverse events
Evaluation of effectiveness Imaging tests Tumor markers CBC SMA PTaPTT are performed according to the need
QoL QuestionnaireEORTC-QLQ-C30 V3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None