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

NCT06127329 | Not Yet Recruiting

• 1 other identifier: 2023-KY-1101-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• ORR

  up to 3 years

• Overall survival (OS)

  up to 3 years

Study Arms (1)

BAI combine with DEB-BACE

EXPERIMENTAL

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.

Procedure: BAI combine with DEB-BACE

Interventions

BAI combine with DEB-BACE 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.

BAI combine with DEB-BACE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gang Wu: lead

Study Sites (1)

Gang Wu

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Gang Wu, M.D

CONTACT

+8613938570175; wuganghenan2015@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)