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NCT Number: 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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Other names: Adebrelimab, Drug-eluting Beads Bronchial Arterial Chemoembolization,DEB-BACE

Primary outcomes

  1. ORR

    Time frame: 1 year

    objective response rate

Secondary outcomes

  1. PFS

    Time frame: 2 years

    Progression Free Survival

  2. OS

    Time frame: 3 years

    Overall Survival

  3. DCR

    Time frame: 3 years

    Disease Control Rate

  4. DoR

    Time frame: 3 years

    Duration of Overall Response

  5. AE

    Time frame: 3 years

    adverse event

Study contacts

Contact information is provided by the study sponsor or research team.

jingtao tong, master

CONTACT

[email protected]

+8615088440328

kaitai liu, doctor

CONTACT

[email protected]

+8613732112205

Sponsors and collaborators

Lead sponsor

Ningbo Medical Center Lihuili Hospital

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 3, 2024
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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