National Phase II Study of Proton Therapy for Hepatocellular Carcinoma in Adults Aiming to Improve Treatment Safety and Outcomes by Reducing Liver Radiation Exposure

What this Trial Is About

Researchers are evaluating proton therapy as a treatment for hepatocellular carcinoma HCC, a type of liver cancer that has a poor prognosis with low survival rates. The study is a national phase II, non-randomized, single-arm trial designed to offer a safer and more effective radiation treatment for fragile patients by reducing the radiation dose to the healthy liver compared to traditional photon-based radiotherapy. The goal is to provide curative treatment to more patients and improve their outlook. All participants will receive proton therapy with a total dose of 67.5 Gray delivered in 15 treatment sessions over three weeks 5 sessions per week at the Danish Center for Particle Therapy. Weekly CT scans will be performed during treatment for quality assurance until no further scans are deemed necessary. The treatment is provided under careful medical supervision and aims to minimize harm to surrounding healthy tissue. Participants will be involved in additional evaluations including blood samples for circulating tumor DNA analysis, questionnaires, and extra examinations before, during, and after treatment. Researchers will monitor safety outcomes such as deaths, radiation-induced liver disease, liver toxicity, hospitalizations, tumor control, quality of life, and survival over a follow-up period of up to five years. The total enrollment period is three years with ongoing assessments to understand long-term effects and treatment feasibility.

A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma