Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Ningbo Medical Center Lihuili Hospital
Sponsor class: OTHER_GOV
First posted: 2024-01-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Primary outcomes:
measure: ORR
timeFrame: 1 year
Secondary outcomes:
measure: PFS
timeFrame: 2 years
measure: OS
timeFrame: 3 years
measure: DCR
timeFrame: 3 years
measure: DoR
timeFrame: 3 years
measure: AE
timeFrame: 3 years
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Kaitai Liu
state: Zhejiang
Study officials:
References: