Atezolizumab and BEvacizumab With STereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-80
SponsorYonsei University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 19 to 80 years old
Liver function Child-Pugh class A
ECOG 0-1
Patient clinically or pathologically diagnosed with hepatocellular carcinoma
Disqualifiers
Brain metastases
Have a history of malignancy other than hepatocellular carcinoma within the last 5 years (except for malignancies with little risk of metastasis or death, e.g., adequately treated cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, tubular carcinoma in situ, or stage 1 uterine cancer.)
Subjects with a high probability of untreated gastric or esophageal varices or bleeding
Serious uncontrolled medical comorbidities
Trial design
Design model
Single group
Treatments tested in this trial
Stereotactic body radiotherapy
RadiationPatients 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.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Patients with advanced hepatocellular carcinomaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 registrationSecondary outcomes
1
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 registration2
Objective response rate
Objective response rate will be ratepresented as a proportion of the total.
Time frame
36 months after registration3
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 registration4
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 registrationSponsors and contacts
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Source ClinicalTrials.gov