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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Carcinoma, Non-Small Cell Lung

Intervention / Treatment
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* Procedure: BAI combine with DEB-BACE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years old, male and female; 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; TNM stages were III-IV; Newly diagnosed, first-line treatment failure, refusal or inability to perform conventional treatment (surgery, chemoradiotherapy); ECOG PS ≤2; Expected survival > 3 months; Sign the informed consent voluntarily, and the compliance is good. Exclusion Criteria: Previously received interventional therapy (iodine particle implantation, ablation, TACE treatment); Combined with extensive and uncontrolled extrapulmonary metastases, such as liver metastasis, bone metastasis, and brain metastasis; Have had or currently having other primary malignant tumors; White blood cell < 3×109/L, platelet count < 50×109/L, HGB < 90 g/L; Hepatic and renal insufficiency (creatinine > 2 mg/L; AST and/or ALT > 2 times the normal upper limit); Coagulation dysfunction (INR > 1.5) or known bleeding disease (except lung cancer combined with hemoptysis), or anticoagulation therapy; Patients with active infection requiring antibiotic treatment; Uncontrolled hypertension, diabetes, and cardiovascular disease with obvious symptoms; contrast agent allergy; Women with pregnancy or lactation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAI combine with DEB-BACE<br>Procedure: BAI combine with DEB-BACE: bronchial infusion chemotherapy combined with drug-loaded microsphere embolization of EqualSpheres First treatment. Only infusion chemotherapy (THP + Platinum + Letitrexed), THP 20  30mg/m2, Nedaplatin 40mg/m2, Letitrexed 3mg/m2. Second treatment. After infusionchemotherapy, EqualSpheres microsphere used for embolization: EqualSpheres microspheres (400 μm) 1tube was loaded and adsorbed THP (40   60mg/m2). End point of embolization: stagnation of blood flow in tumor feeding artery. | Procedure: BAI combine with DEB-BACE<br>* First treatment. Only infusion chemotherapy (THP + Platinum + Letitrexed), THP 20  30mg/m2, Nedaplatin 40mg/m2, Letitrexed 3mg/m2. Second treatment. After infusionchemotherapy, EqualSpheres microsphere used for embolization: EqualSpheres microspheres (400 μm) 1tube was loaded and adsorbed THP (40   60mg/m2). End point of embolization: stagnation of blood flow in tumor feeding artery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | ORR is defined as the percentages of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria | up to 3 years | 
| Overall survival (OS) | The time from recruitment to death due to any cause. | up to 3 years |