Phase II Study of Carbon Ion Radiotherapy for Hepatocellular Carcinoma After Prior Transarterial Radioembolization TARE Evaluating Safety and Effectiveness in Patients with Residual or Recurrent Liver Tumors

What this Trial Is About

Researchers are evaluating the safety and effectiveness of carbon ion radiotherapy in patients with hepatocellular carcinoma HCC who have residual or recurrent disease after prior transarterial radioembolization TARE. This prospective, single-arm Phase II study aims to see if this advanced radiation treatment can provide better local tumor control while minimizing harm to surrounding healthy tissues. Patients with limited treatment options after TARE are the focus of this investigation. Participants will receive carbon ion radiotherapy targeted at liver tumors, delivered using a hypofractionated, high-linear energy transfer approach. The dose and schedule will be personalized based on tumor size, location, and nearby organ safety limits. This treatment is designed to increase tumor-killing doses while protecting liver function and adjacent gastrointestinal organs. The study does not include a comparison group and focuses on evaluating this single intervention. During the study, patients will undergo baseline assessments and multidisciplinary review before treatment. Follow-up will include scheduled imaging, lab tests, and toxicity monitoring to assess outcomes such as tumor response, progression-free survival, overall survival, and treatment-related side effects. The primary outcome is objective response rate up to 6 months after therapy. Secondary outcomes include survival measures and safety assessed up to 3 years. The study participation may last several years to monitor long-term effects and disease progression.

A Single-arm Phase II Clinical Study Investigating the Safety and Efficacy of Carbon Ion Radiotherapy in Patients With Hepatocellular Carcinoma Previously Treated With Transarterial Radioembolization (TARE)