Status:

RECRUITING

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

Lead Sponsor:

Ningbo Medical Center Lihuili Hospital

Conditions:

Non-Small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

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 af...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 9 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 30 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06188650

Start Date

December 9 2023

End Date

September 30 2026

Last Update

January 3 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Kaitai Liu

Ningbo, Zhejiang, China, 315040

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 | DecenTrialz