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

NCT ID: NCT06127329

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2026-12-01

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.

Conditions

Carcinoma, Non-Small Cell Lung

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BAI combine with DEB-BACE

Intervention Type: PROCEDURE

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.

Interventions

BAI combine with DEB-BACE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gang Wu

OTHER

Sponsor Role: lead

Responsible Party

Gang Wu

Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Gang Wu

Zhengzhou, Henan, China

Countries

China

Central Contacts

Gang Wu, M.D

Role: CONTACT

wuganghenan2015@163.com

+8613938570175

Facility Contacts

Gang Wu, M.D

Role: primary

wuganghenan2015@163.com

+8613938570175

Other Identifiers

2023-KY-1101-001

Identifier Type: -

Identifier Source: org_study_id