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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

NCT06127329•Gang Wu

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Gang Wu

Zhengzhou, Henan, China

Key Dates

Start Date

December 1, 2023

Primary Completion Date

December 1, 2024

Completion Date

December 1, 2026

Last Updated

November 13, 2023

Enrollment

ESTIMATED participants

Conditions

Carcinoma, Non-Small Cell Lung

Interventions

BAI combine with DEB-BACE

PROCEDURE

Contacts

Gang Wu, M.D

CONTACT

+8613938570175 wuganghenan2015@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of SGN-B6A in Chinese Participants With Advanced Solid Tumors

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