Non-Small Cell Lung Cancer Clinical Trial
Official title:
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 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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 30, 2026 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
China | Kaitai Liu | Ningbo | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Ningbo Medical Center Lihuili Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ORR | objective response rate | 1 year | |
Secondary | PFS | Progression Free Survival | 2 years | |
Secondary | OS | Overall Survival | 3 years | |
Secondary | DCR | Disease Control Rate | 3 years | |
Secondary | DoR | Duration of Overall Response | 3 years | |
Secondary | AE | adverse event | 3 years |
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