A Prospective, Single-Center, Randomized Controlled Trial to Evaluate the Clinical Efficacy and Safety of Microwave Ablation Combined With Huaier Granules in Patients With Stage IA Non-Small Cell Lung Cancer

Lung cancer remains the leading cause of cancer-related death globally, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of cases. A significant proportion of early-stage NSCLC patients are deemed inoperable due to comorbidities or patient refusal. Microwave ablation (MWA) is an established local therapy for inoperable NSCLC, yet incomplete ablation and immune suppression in the tumor microenvironment remain challenges, especially in tumors >3 cm or near critical structures.

This study investigates whether the addition of Huaier granules, a polysaccharide-based traditional Chinese medicine shown to modulate immune function and improve outcomes post-ablation in liver cancer, can enhance the efficacy of MWA in early-stage NSCLC. Huaier may promote dendritic cell maturation, Th1 immune responses, and restore immune balance after incomplete MWA (iMWA).

Eligible patients (stage IA-IIA NSCLC without lymph node metastasis, ECOG ≤2, life expectancy >3 months) will be randomized 1:1 into two groups. The experimental group will receive CT-guided MWA followed by oral Huaier granules (10 g three times daily for 72 weeks), while the control group receives MWA alone. Follow-up will occur at months 1, 3, 6, 12, and 24.

Primary endpoint: progression-free survival (PFS). Secondary endpoints: local progression rate (LPR), overall survival (OS), immune cell profiles, tumor markers (e.g., CEA, CYFRA21-1), and quality of life (EORTC QLQ-C30/LC13).

Safety will be monitored via laboratory tests and adverse event reporting according to CTCAE v5.0.