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

Gang Wu1 site in 1 country70 target enrollmentDecember 1, 2023

ConditionsCarcinoma, Non-Small Cell Lung

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Carcinoma, Non-Small Cell Lung
Sponsor: Gang Wu
Enrollment: 70
Locations: 1
Primary Endpoint: PFS
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 1, 2023

End Date

December 1, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Gang Wu

Responsible Party

Sponsor Investigator

Principal Investigator

Gang Wu

Chief physician

The First Affiliated Hospital of Zhengzhou University

Eligibility Criteria

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.