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

NCT06188650 | Recruiting

• 1 other identifier: KY2023PJ261
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  objective response rate

  1 year

Secondary Outcomes (5)

• PFS

  2 years

• OS

  3 years

• DCR

  3 years

• DoR

  3 years

• AE

  3 years

Study Arms (1)

experimental group

EXPERIMENTAL

Drug: Anlotinib

Interventions

Anlotinib DRUG

After receiving DEB-BACE treatment, the enrolled patients will rest for one week and then undergo one cycle of treatment with the combination of Anlotinib and Adebelimumab. After one course of treatment, the efficacy will be re evaluated, such as CR, and the treatment with Anlotinib and Adebelimumab will continue; For PR, SD, or PD, continue to receive DEB-BACE combined with anlotinib and adebelimumab as needed, with a maximum of 4 DEB-BACE treatments, followed by continued treatment with anlotinib and adebelimumab

Also known as: Adebrelimab, Drug-eluting Beads Bronchial Arterial Chemoembolization，DEB-BACE

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Ningbo Medical Center Lihuili Hospital: lead

Study Sites (1)

Kaitai Liu

Ningbo, Zhejiang, 315040, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

kaitai liu, doctor

CONTACT

+8613732112205; liukaitai@nbu.edu.cn

jingtao tong, master

CONTACT

+8615088440328; vanssi@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: December 9, 2023
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)