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 now · Not applicable
Conditions studied: Non-Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT06188650
- Run by
- Ningbo Medical Center Lihuili Hospital
- People needed
- 30
- Starts
- 2023-12-09
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2024-01-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Kaitai Liu — Ningbo, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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