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

Not Applicable

Not yet recruiting

• Conditions: Carcinoma, Non-Small Cell Lung
• Interventions: Procedure: BAI combine with DEB-BACE

• Registration Number: NCT06127329
• Lead Sponsor: Gang Wu

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-07
• Last Update Submitted: 2023-11-07
• Study First Posted: 2023-11-13
• Last Update Posted: 2023-11-13
• Study Start: 2023-12-01
• Primary Completion: 2024-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BAI combine with DEB-BACE	BAI combine with DEB-BACE	Procedure: BAI combine with DEB-BACE: bronchial infusion chemotherapy combined with drug-loaded microsphere embolization of EqualSpheres 1. First treatment. Only infusion chemotherapy (THP + Platinum + Letitrexed), THP 20 \~30mg/m2, Nedaplatin 40mg/m2, Letitrexed 3mg/m2. 2. 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.

Primary Outcome Measures

Name	Time	Method
PFS	up to 3 years	PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.

Secondary Outcome Measures

Name	Time	Method
ORR	up to 3 years	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
Overall survival (OS)	up to 3 years	The time from recruitment to death due to any cause.

Trial Locations

Locations (1)

Gang Wu; 🇨🇳 Zhengzhou, Henan, China