This prospective, single-center, randomized controlled clinical trial aims to evaluate the efficacy and safety of microwave ablation (MWA) combined with Huaier granules in patients with inoperable stage IA non-small cell lung cancer (NSCLC). A total of 180 eligible patients will be randomly assigned to receive either MWA alone or MWA combined with Huaier granules. The primary endpoint is progression-free survival (PFS) assessed by RECIST 1.1 criteria. Secondary outcomes include local progression rate (LPR), overall survival (OS), tumor markers, immune function, and quality of life. Safety will be evaluated using the CTCAE v5.0 criteria. The study seeks to determine whether the combined therapy offers improved tumor control and immune benefits over MWA alone.
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Parallel
Huaier Granule
DrugPatients in this arm will undergo CT-guided percutaneous microwave ablation using a standard protocol (2450 MHz, 30-50 W, 5-10 minutes per lesion, multi-probe as needed based on tumor size). Seven days post-ablation, patients will start oral administration of Huaier granules at a dose of 10g, three times daily (TID), for 72 consecutive weeks. The combined therapy aims to improve local tumor control and modulate anti-tumor immunity.
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to disease progression or death from any cause, whichever occurs first. Disease progression will be assessed based on RECIST 1.1 criteria through imaging evaluations. Patients who are alive and progression-free at the time of analysis will be censored at their last disease assessment.
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Xin Ye
Lead sponsor
Qianfoshan Hospital
Sponsor institution
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