Phase II Trial Comparing Stereotactic Radiosurgery and Radiofrequency Ablation for Inoperable Primary Liver Cancer Near Major Structures

What this Trial Is About

Researchers are evaluating treatment options for patients with primary liver cancer who cannot undergo surgery due to tumor location near critical areas like major blood vessels, the diaphragm, liver capsule, or liver hilum. This phase II clinical trial compares the safety and effectiveness of stereotactic radiosurgery and radiofrequency ablation in these patients. The study aims to determine which treatment is preferred for tumors in these challenging locations. Participants will be randomly assigned to one of two treatment groups one receiving stereotactic body radiation therapy SBRT with a total dose of 40 to 50 Gy delivered over 3 to 5 sessions, and the other receiving a single complete radiofrequency ablation procedure targeting the liver lesions. The study plans to enroll 65 patients in each group, with treatments delivered based on investigator assessment and randomization. During the study, participants will undergo regular imaging and clinical evaluations to measure progression-free survival, overall survival rates, and control rates of the tumor both locally and in other parts of the liver or body. These assessments will continue for about two years. The research team will monitor liver function, organ health, and respiratory stability, ensuring patient safety and treatment adherence throughout the trial period.

Stereotactic Radiosurgery Versus Radiofrequency Ablation for Primary Liver Cancer