Efficacy and Safety of BAI Combined With DEB-BACE of EqualSpheres in the Treatment of Advanced NSCLC

Efficacy and Safety of Bronchial Infusion Chemotherapy Combined With Drug-loaded Microsphere Embolization of EqualSpheres in the Treatment of Advanced Non-small Cell Lung Cancer

This is a prospective, single-arm, open-label study designed to evaluate the efficacy and safety of bronchial infusion chemotherapy（BAI） combined with drug-loaded microsphere embolization of EqualSpheres in advanced Non-small cell lung cancer (NSCLC). Progression-free survival (PFS) will be evaluated as the primary endpoint.

Inclusion Criteria:

1. Age > 18 years old, male and female;
2. According to the Guidelines for the Diagnosis and Treatment of Primary Lung Cancer (2022 edition), the patient was diagnosed with NSCLC by imaging and histopathology;
3. TNM stages were III-IV;
4. Newly diagnosed, first-line treatment failure, refusal or inability to perform conventional treatment (surgery, chemoradiotherapy);
5. ECOG PS ≤2;
6. Expected survival > 3 months;
7. Sign the informed consent voluntarily, and the compliance is good.

Exclusion Criteria:

1. Previously received interventional therapy (iodine particle implantation, ablation, TACE treatment);
2. Combined with extensive and uncontrolled extrapulmonary metastases, such as liver metastasis, bone metastasis, and brain metastasis;
3. Have had or currently having other primary malignant tumors;
4. White blood cell < 3×109/L, platelet count < 50×109/L, HGB < 90 g/L;
5. Hepatic and renal insufficiency (creatinine > 2 mg/L; AST and/or ALT > 2 times the normal upper limit);
6. Coagulation dysfunction (INR > 1.5) or known bleeding disease (except lung cancer combined with hemoptysis), or anticoagulation therapy;
7. Patients with active infection requiring antibiotic treatment;
8. Uncontrolled hypertension, diabetes, and cardiovascular disease with obvious symptoms;
9. contrast agent allergy;
10. Women with pregnancy or lactation.