The Efficacy and Safety of Drug Loaded Microsphere Bronchial Artery Chemoembolization (DEB-BACE) Combined With Anlotinib and Adebelimumab in the Third Line Treatment of Advanced NSCLC: a Prospective, Single Arm, Single Center, Exploratory Clinical Study

Ningbo Medical Center Lihuili Hospital1 site in 1 country30 target enrollmentDecember 9, 2023

ConditionsNon-Small Cell Lung Cancer

InterventionsAnlotinib

DrugsAnlotinib

Overview

Phase: Not Applicable
Intervention: Anlotinib
Conditions: Non-Small Cell Lung Cancer
Sponsor: Ningbo Medical Center Lihuili Hospital
Enrollment: 30
Locations: 1
Primary Endpoint: ORR
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to learn about Drug loaded microspheres for bronchial artery chemoembolization (DEB-BACE) combined with anlotinib and adebelimumab in patients with advanced NSCLC after second-line treatment.

The main question it aims to answer is:

The efficacy and safety of Drug Loading Beads Bronchial Arterial Chemoembolization (DEB-BACE) combined with Anlotinib and Adebelimumab in the third line treatment of advanced NSCLC.

Participants will receive DEB-BACE treatment, rest for 1 week and then undergo 1 cycle of treatment with combination of Anlotinib and Adebelimumab. With a maximum of 4 DEB-BACE treatments depending on the therapeutic effect, followed by continued treatment with Anlotinib and Adebelimumab.

Registry

clinicaltrials.gov

Start Date

December 9, 2023

End Date

September 30, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ningbo Medical Center Lihuili Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age\>18 years old, gender unlimited;
•According to the Diagnosis and Treatment Guidelines for Primary Lung Cancer (2018 Edition), NSCLC was diagnosed by pathological histology;
•TNM staging is III - IV;
•Failure of second-line treatment according to the CSCO guidelines;
•ECOG PS score ≤ 2 points;
•Estimated survival time\>3 months;
•Sign informed consent form

Exclusion Criteria

•Individuals who have previously received interventional therapy (iodine particle implantation, ablation, BACE treatment), or have received PD-L1 inhibitor immunotherapy during the first or second line standard treatment period of the patient;
•Patients with other malignant tumors that have not been cured;
•White blood cells\<3 × 109/L, absolute value of neutrophils\<1.5 × 109/L, neutrophil/lymphocyte ratio ≥ 3, platelet count\<50 × 109/L, hemoglobin concentration\<90 g/L;
•Liver and kidney dysfunction (creatinine\>176.8) μ Mol/L; Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)\>twice the normal upper limit;
•Central squamous cell carcinoma with cavity features;
•Incorrectable coagulation dysfunction or concomitant active massive hemoptysis;
•Patients with concurrent active infections who require antibiotic treatment;
•Uncontrollable hypertension, diabetes, and cardiovascular diseases with obvious symptoms;
•Contrast agent allergy;
•Women with concurrent pregnancy or lactation