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

Not Applicable

Not yet recruiting

• Conditions: Non-small Cell Lung Cancer (NSCLC); Huaier Granules; Microwave Ablation
• Interventions: Drug: Huaier Granule

• Registration Number: NCT07197853
• Lead Sponsor: Xin Ye

Brief 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.

Detailed Description

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.

The trial is expected to provide high-level evidence on whether the integration of Huaier granules into MWA-based therapy improves clinical outcomes and immune recovery in early inoperable NSCLC.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-26
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-09-29
• Last Update Posted: 2025-09-29
• Study Start: 2025-10-01
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MWA + huaier	Huaier Granule	MWA + huaier
MWA	Huaier Granule	MWA

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Up to 24 months after treatment initiation	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.