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

Carcinoma, Non-Small Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06127329
• Other study ID #: 2023-KY-1101-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: November 2023
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Gang Wu, M.D
• Phone: +8613938570175
• Email: wuganghenan2015[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small Cell Lung
• Carcinoma, Non-Small-Cell Lung

Intervention

Procedure:
• BAI combine with DEB-BACE
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.

Locations

Country	Name	City	State
China	Gang Wu	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Gang Wu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Overall survival (OS)	The time from recruitment to death due to any cause.	up to 3 years