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

Not Applicable

Recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Anlotinib

• Registration Number: NCT06188650
• Lead Sponsor: Ningbo Medical Center Lihuili Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12-09
• Study First Submitted: 2023-12-18
• Study First Submitted QC: 2023-12-18
• Last Update Submitted: 2023-12-18
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03
• Primary Completion: 2025-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	Anlotinib	-

Primary Outcome Measures

Name	Time	Method
ORR	1 year	objective response rate

Secondary Outcome Measures

Name	Time	Method
DoR	3 years	Duration of Overall Response
AE	3 years	adverse event
OS	3 years	Overall Survival
PFS	2 years	Progression Free Survival
DCR	3 years	Disease Control Rate

Trial Locations

Locations (1)

Kaitai Liu; 🇨🇳 Ningbo, Zhejiang, China