Efficacy and Safety of Multimode Thermal Therapy in the Treatment of Early Peripheral Lung Cancer

This is a single-center, single-arm, exploratory study, and is expected to enroll a total of 10 patients. The enrolled patients were stage IA lung cancer patients with lung lesions found on chest CT, pathologically diagnosed as non-small cell lung cancer, negative for driver gene mutations, and who were considered high-risk or refused surgery by multidisciplinary evaluation. Follow-ups are performed after the multimode thermal therapy. The primary endpoint is complete ablation rate at 6 months after multimode thermal therapy. The secondary endpoints are complete ablation rate at 12 months after multimode thermal therapy, local control rate at 1, 2, 3 years post-procedure, progression-free survival and mmune effects after multimodal thermal therapy.

Inclusion criteria

• Age ≥18 years old;
• Pathologically diagnosed as primary peripheral non-small cell lung cancer, preoperative staging suggested clinical staging as T1N0M0, stage IA (including new-onset lung cancer after surgery and multiple primary lung cancer);
• The ECOG PS score is 0-2;
• Expected survival ≥6 months;
• Negative driver gene mutation: driver genes were defined as EGFR, ALK, ROS1, RET;
• Agree to undergo multimode thermal therapy as initial treatment after being assessed unsuitable for surgery or refusing surgery, and sign informed consent.

Exclusion criteria

• Patients with poor cardiopulmonary function or other comorbidities who cannot tolerate multimode thermal therapy;
• Patients whose chest CT indicated that the lung lesions could not be reached through the chest wall through multimode thermal therapy;
• Severe liver and kidney function and coagulation function abnormalities, platelet count <70×109/L;
• Poor control of malignant pleural effusion;
• Patients who have received other anti-tumor drugs or have used immune checkpoint inhibitors in the past 6 months;
• The patient has an uncontrolled disease (including but not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia, mental illness, etc.);
• Those who have undergone surgical operations or had allogeneic organ transplants within 1 month;
• Primary immune deficiency or autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.);
• Pregnant and lactating women;
• Long-term use of steroid;
• Other circumstances considered inappropriate for participation in this study.