Phase II Study of Ablation Therapy for Lung Cancer with Ground-Glass Nodules Evaluating Safety and Effectiveness in Patients Aged 18 to 85 Years

What this Trial Is About

Researchers are conducting a phase II clinical study at two centers to assess the safety and effectiveness of ablation therapy for treating lung cancer that appears as ground-glass nodules on lung CT scans. This study focuses on patients with such nodules that have not decreased after 3 months and meet specific size and progression criteria. The study is sponsored by Shanghai Zhongshan Hospital and aims to provide important data on this treatment approach for lung cancer progression. Participants will receive ablation therapy targeting ground-glass nodules in the lungs. This single-arm study involves no comparison group and no blinding. Ablation therapy is being evaluated as an alternative for patients who cannot tolerate surgery or have multiple nodules that cannot be fully removed by operation. The treatment focuses on nodules larger than 8 mm but smaller than 3 cm, especially those showing progression. During the study, participants will be monitored for progression-free survival over one year as the primary outcome. Secondary outcomes include overall survival evaluated at one, three, and five years. Participants will undergo lung CT scans and other assessments as needed to track treatment effects and safety. The total participation period extends up to five years for long-term follow-up of survival outcomes.

A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules