drugset / Trial / NCT05908916

Atezolizumab and Bevacizumab With Combined Radiotherapy for Advanced Hepatocellular Carcinoma

NCT05908916 ↗

Phase 2 Not yet recruiting 51 enrolled Yonsei University
NaSingle-groupOpen-labelTreatment

Summary

Atezolizumab plus Bevacizumab combination therapy (AtezoBev) is well-known 1st-line therapy for advanced hepatocellular carcinoma (HCC). However, there are unmet needs for patients with advanced HCC who do not respond to AtezoBev. External beam radiotherapy (RT) is another well-known locoregional therapy for HCC that induces inflammatory cascade and abscopal effect as a systemic anticancer effect and enhances the effect of AtezoBev. Therefore, the investigators aim to verify the effect of AtezoBev plus RT for advanced HCC through this single-center, prospective phase II one-armed cohort study over three years. This study recruits 51 patients to verify the effect of the intervention. Atezolizumab (1200mg) and Bevacizumab (15mg/kg) are administered to patients once for each cycle at 3-week intervals, and additional radiotherapy for the mass or portal vein tumor thrombosis is performed before second cycle of AtezoBev. The primary endpoint is progression-free survival by using response evaluation with modified RECIST.

Timeline

Start
2023-07
Primary completion
2025-07
Completion
2026-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg —
Subject Bevacizumab Monoclonal antibody 15 mg/kg —