Clinical Research Directory
Browse clinical research sites, groups, and studies.
Clinical Efficacy and Safety of Microwave Ablation Combined With Huaier Granules in Patients With Inoperable Stage IA Non-Small Cell Lung Cancer: A Prospective, Single-Center, Randomized Controlled Clinical Trial
Sponsor: Xin Ye
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2025-10-01
Completion Date
2028-06-30
Last Updated
2025-09-29
Healthy Volunteers
No
Interventions
Huaier Granule
Patients 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.