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

Inclusion Criteria

Age:

≥ 18 years old.

Diagnosis:

Histologically or cytologically confirmed IA stage non-small cell lung cancer (NSCLC) that is inoperable.

ECOG Performance Status:

0-2 (Eastern Cooperative Oncology Group performance status).

Previous Treatment:

Patients must have received no prior systemic treatment for lung cancer.

Informed Consent:

Ability to provide written informed consent and willingness to comply with study requirements.

Adequate Organ Function:

Patients must have adequate hepatic, renal, and hematologic function as evidenced by:

Bilirubin ≤ 1.5 × upper limit of normal (ULN)

ALT/AST ≤ 2.5 × ULN

Creatinine clearance ≥ 30 mL/min

Absolute neutrophil count (ANC) ≥ 1,500 cells/μL

Exclusion Criteria

Other Malignancies:

Active or history of other malignancies within the past 5 years, except for non-melanoma skin cancer or in situ carcinoma.

Severe Concurrent Diseases:

Any serious or uncontrolled medical condition such as:

Cardiovascular disease (e.g., recent myocardial infarction, unstable angina, or severe arrhythmia)

Uncontrolled diabetes or hypertension

Active infections requiring systemic antibiotics or antivirals

Pregnancy or Breastfeeding:

Women who are pregnant, breastfeeding, or planning to become pregnant during the study.

Immunosuppressive Therapy:

Patients who have received immunosuppressive therapy within 30 days prior to enrollment.

Other Contraindications:

Known hypersensitivity to any of the components of the treatment regimen (e.g., microwave ablation, Huai Er Granules).

Other Unspecified Conditions:

Any other condition or circumstances that, in the investigator's opinion, may interfere with the study or pose a risk to the patient.

\-