RecruitingNot ApplicableNCT06595108

Atezolizumab and BEvacizumab With STereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma

Atezolizumab and Bevacizumab With Stereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma

Sponsor

Yonsei University

Enrollment

33 participants

Start Date

May 28, 2024

Study Type

INTERVENTIONAL

Conditions

Chemotherapy Advanced Hepatocellular Carcinoma Stereotactic Body Radiotherapy

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

Min Age: 19 YearsMax Age: 80 Years

Inclusion Criteria6

Age 19 to 80 years old
Liver function Child-Pugh class A
ECOG 0-1
Patient clinically or pathologically diagnosed with hepatocellular carcinoma
Advanced hepatocellular carcinoma that is inoperable
Satisfies the dose limits for normal organs and lesions of an appropriate size to be included in the scope of radiotherapy.

Exclusion Criteria6

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
History of liver transplant surgery
Autoimmune liver disease

Interventions

RADIATIONStereotactic 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.