Evaluating Proton Radiotherapy Combined With Tremelimumab and Durvalumab for Treating Intermediate and Advanced Hepatocellular Carcinoma

What this Trial Is About

Researchers are evaluating a combination treatment including proton radiotherapy with the drugs tremelimumab and durvalumab for patients with unresectable hepatocellular carcinoma HCC at intermediate to advanced stages. This phase II trial aims to assess the safety, effectiveness, and immune effects of this combined approach since current therapies show limited response rates. Proton radiotherapy offers precise targeting with less damage to healthy tissue, and early data suggest that combining it with immune checkpoint inhibitors may improve tumor response. Participants will receive proton radiotherapy with doses adjusted based on tumor location and size 72.6 CGE in 22 fractions for tumors close to vital organs and 66 CGE in 10 fractions for more distant tumors. Tremelimumab will be given as a single intravenous infusion of 300 mg, while durvalumab will be administered intravenously every 4 weeks at 1500 mg. Treatment duration with durvalumab depends on response, continuing up to two years for complete or partial responders and shorter for stable disease. During the study, participants will undergo regular clinical assessments including evaluation of progression-free survival over 12 months as the primary outcome. Other measures include tumor control, time to progression, overall response rate, survival, and monitoring of adverse events within one year. Patients will be monitored closely for safety and treatment effects throughout, with a total participation period aligned with these outcome assessments.

Proton Radiotherapy Plus Tremelimumab/Durvalumab for BCLC Stage B and C HCC