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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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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;
  2. Patients with other malignant tumors that have not been cured;
  3. 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;
  4. Liver and kidney dysfunction (creatinine>176.8) μ Mol/L; Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>twice the normal upper limit;
  5. Central squamous cell carcinoma with cavity features;
  6. Incorrectable coagulation dysfunction or concomitant active massive hemoptysis;
  7. Patients with concurrent active infections who require antibiotic treatment;
  8. Uncontrollable hypertension, diabetes, and cardiovascular diseases with obvious symptoms;
  9. Contrast agent allergy;
  10. Women with concurrent pregnancy or lactation

Study details
    Non-Small Cell Lung Cancer

NCT06188650

Ningbo Medical Center Lihuili Hospital

27 January 2024

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