NCT06595108

Atezolizumab and BEvacizumab With STereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma

Atezolizumab and Bevacizumab With Stereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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 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 * 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, PT/aPTT, Tumor markers, Biomarkers * Stool microbiota NGS * QoL Questionnaire(EORTC-QLQ-C30 V3) Visit 2 (0\~7 weeks) ± 7 days \*During SBRT * Confirmation of adverse events * QoL Questionnaire(EORTC-QLQ-C30 V3) Visit 3 (1\~8 weeks) \*1 week after SBRT * Confirmation of adverse events * CBC, SMA, PT/aPTT, Tumor markers, Biomarkers * QoL Questionnaire(EORTC-QLQ-C30 V3) Visit 4 (6\~9 weeks) ± 7 days \*After 2 cycles of chemotherapy * Confirmation of adverse events * CBC, SMA, PT/aPTT, Tumor markers, Biomarkers * Stool microbiota NGS * QoL Questionnaire(EORTC-QLQ-C30 V3) Visit: 5\~12 (3\~36 months) ± 2 weeks \*Follow-up * Confirmation of adverse events * Evaluation of effectiveness\* (Imaging tests, Tumor markers, CBC, SMA, PT/aPTT are performed according to the need) * QoL Questionnaire(EORTC-QLQ-C30 V3)

Conditions

• Advanced Hepatocellular Carcinoma
• Chemotherapy
• Stereotactic Body Radiotherapy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-28
• Primary completion: 2027-04-25
• Completion: 2028-03-27
• First posted: 2024-09-19
• Last updated: 2024-11-01

Locations

1 site across 1 country: South Korea