An interventional study of Stereotactic body radiotherapy in Advanced Hepatocellular Carcinoma, Chemotherapy and Stereotactic Body Radiotherapy, sponsored by Yonsei University. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-01.
Sponsored by Yonsei University · Not applicable, Interventional, and Treatment
To determine the efficacy and safety of atezolizumab-bevacizumab combination therapy plus stereotactic body radiotherapy(SBRT) in patients with advanced hepatocellular carcinoma, Subjects will start SBRT for one or more primary cancers and/or 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.
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 SBRT(stereotactic body radiotherapy) to one or more but not more than five sites for primary cancer and/or 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 (-6\~0 weeks) ± 7days *Screening
Visit 2 (0\~7 weeks) ± 7 days *During SBRT
Visit 3 (1\~8 weeks) *1 week after SBRT
Visit 4 (6\~9 weeks) ± 7 days *After 2 cycles of chemotherapy
Visit: 5\~12 (3\~36 months) ± 2 weeks *Follow-up
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 33 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
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Exclusion Criteria:
Patients indicated for the first-line atezolizumab-bevacizumab combination therapy are the primary subjects, and those voluntarily agree to the clinical trial after explanation of the study, are enrolled in the study.
Radiation: Stereotactic body radiotherapy
Patients with advanced hepatocellular carcinoma who are indicated for the first-line atezolizumab-bevacizumab combination therapy are the primary subjects, and they should begin stereotactic radiotherapy to one or more but not more than five sites for primary cancer and/or metastatic lesions within two month before and after the start date of atezolizumab-bevacizumab combination therapy.
Progression-free survival at 6 month
The primary endpoint is to improve 6-month progression-free survival rate in the treatment group compared to those existing literature. Progression-free survival and overall survival are evaluated using the Kaplan-Meier curve. Verified through one sample proportion test.
Time frame: 6 months after registration
Overall survival
Progression-free survival and overall survival are evaluated using the Kaplan-Meier curve. Verified through one sample proportion test.
Time frame: 36 months after registration
Objective response rate
Objective response rate will be ratepresented as a proportion of the total.
Time frame: 36 months after registration
Adverse event (Toxicity)
Toxicity will be evaluated using CTCAE version 5.0 and presented as a proportion of the total.
Time frame: 36 months after registration
Tumor marker response: AFP, PIVKA-II
Tumor markers and biological markers are descriptive as statistics such as mean, standard deviation, and median for continuous data will be presented, and changes in values before and after treatment will be compared and evaluated using paired t-test or Wilcoxon signed rank test.
Time frame: 36 months after registration
Plan to share: No
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