Advanced Hepatocellular CarcinomaChemotherapyStereotactic Body Radiotherapy
Investigational drug(s) / intervention(s)
Stereotactic body radiotherapy
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.
Study summary
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
Sex
ALL
Min age
19 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 19 to 80 years old
2. Liver function Child-Pugh class A
3. ECOG 0-1
4. Patient clinically or pathologically diagnosed with hepatocellular carcinoma
5. Advanced hepatocellular carcinoma that is inoperable
6. Satisfies the dose limits for normal organs and lesions of an appropriate size to be included in the scope of radiotherapy.
Exclusion Criteria:
1. Brain metastases
2. 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.)
3. Subjects with a high probability of untreated gastric or esophageal varices or bleeding
4. Serious uncontrolled medical comorbidities
5. History of liver transplant surgery
6. Autoimmune liver disease
Primary outcome measure(s)
Progression-free survival at 6 month — 6 months after registration 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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