Phase II Study of Durvalumab With or Without Tremelimumab After Hypofractionated Radiation Therapy for Advanced Liver Cancer

What this Trial Is About

Researchers are evaluating how well standard hypofractionated radiation therapy followed by durvalumab with or without tremelimumab works in treating patients with advanced hepatocellular carcinoma liver cancer that has spread and is progressing. This phase II trial focuses on patients whose cancer cells and immune cells express signals that block the immune system, and these new drugs are designed to block those signals to potentially improve the immune response. Hypofractionated radiation delivers higher doses over a shorter time, possibly enhancing immune effects against cancer. All participants receive five daily radiation treatments to areas needing symptom relief or at high risk. Participants are assigned to one of three treatment groups durvalumab alone after radiation durvalumab combined with a single dose of tremelimumab following progression on prior PD-L1 checkpoint inhibitors or durvalumab combined with tremelimumab for those without prior PD-L1 therapy. Treatments start within 3 to 10 days after radiation and continue every 28 days for up to two years unless disease worsens or side effects occur. During the study, participants undergo regular assessments including tumor scans to measure response by RECIST criteria, blood tests to monitor immune cells and liver function, and safety evaluations. Researchers will also analyze tumor tissue samples when available to study immune changes and treatment effects. After up to two years of treatment, ongoing benefits are evaluated case-by-case, with survival follow-up continuing for about three years from treatment start.

Durvalumab With/Without Tremelimumab After Palliative Hypofractionated Radiotherapy for Hepatocellular Carcinoma