NCT06188650 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
| NCT ID | NCT06188650 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ningbo Medical Center Lihuili Hospital |
| Condition | Non-Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-12-09 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-12-09 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06188650 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06188650 currently recruiting?
Yes, NCT06188650 is actively recruiting participants. Contact the research team at liukaitai@nbu.edu.cn for enrollment information.
Where is the NCT06188650 trial being conducted?
This trial is being conducted at Ningbo, China.
Who is sponsoring the NCT06188650 clinical trial?
NCT06188650 is sponsored by Ningbo Medical Center Lihuili Hospital. The trial plans to enroll 30 participants.
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