Phase II Study of Carbon Ion Radiotherapy Combined with Atezolizumab and Bevacizumab for Advanced Liver Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of adding carbon ion radiotherapy to the standard treatment of atezolizumab and bevacizumab in patients with advanced hepatocellular carcinoma, a type of liver cancer. This phase II clinical trial aims to see if combining these treatments improves tumor control and clinical outcomes such as overall survival, progression-free survival, and response rates compared to systemic therapy alone. The study is sponsored by Yonsei University and will follow participants over a three-year period. Participants will receive standard first-line systemic therapy with atezolizumab 1200 mg intravenously every three weeks and bevacizumab 15 mgkg intravenously every three weeks. During the early phase of this systemic therapy, carbon ion radiotherapy will be given to the primary liver tumor using a hypofractionated schedule of about 4 to 12 treatment sessions. The exact dose and schedule will be customized based on tumor size and location to protect nearby organs. After finishing radiotherapy, participants will continue maintenance therapy with atezolizumab and bevacizumab until disease progression, unacceptable side effects, or withdrawal. Throughout the study, participants will be monitored for treatment response and safety using imaging tests and clinical evaluations. Key measures include progression-free survival over three years, overall survival, tumor response, treatment-related side effects graded by standard criteria, and the rate of tumor down-staging. The study also requires participants to have stable liver function and meet specific blood count and organ function criteria. Follow-up visits will allow the research team to track outcomes and manage any adverse events during the trial period, which is expected to end in March 2028.

A Phase II Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Carbon Ion Radiotherapy With Atezolizumab and Bevacizumab Combination Therapy in Patients With Advanced Hepatocellular Carcinoma