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NCT Number: NCT06127329

Efficacy and Safety of BAI Combined With DEB-BACE of EqualSpheres in the Treatment of Advanced NSCLC

This is a prospective, single-arm, open-label study designed to evaluate the efficacy and safety of bronchial infusion chemotherapy(BAI) combined with drug-loaded microsphere embolization of EqualSpheres in advanced Non-small cell lung cancer (NSCLC). Progression-free survival (PFS) will be evaluated as the primary endpoint.

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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, male and female;
  • According to the Guidelines for the Diagnosis and Treatment of Primary Lung Cancer (2022 edition), the patient was diagnosed with NSCLC by imaging and histopathology;
  • TNM stages were III-IV;
  • Newly diagnosed, first-line treatment failure, refusal or inability to perform conventional treatment (surgery, chemoradiotherapy);
  • ECOG PS ≤2;
  • Expected survival > 3 months;
  • Sign the informed consent voluntarily, and the compliance is good.

Exclusion criteria

  • Previously received interventional therapy (iodine particle implantation, ablation, TACE treatment);
  • Combined with extensive and uncontrolled extrapulmonary metastases, such as liver metastasis, bone metastasis, and brain metastasis;
  • Have had or currently having other primary malignant tumors;
  • White blood cell < 3×109/L, platelet count < 50×109/L, HGB < 90 g/L;
  • Hepatic and renal insufficiency (creatinine > 2 mg/L; AST and/or ALT > 2 times the normal upper limit);
  • Coagulation dysfunction (INR > 1.5) or known bleeding disease (except lung cancer combined with hemoptysis), or anticoagulation therapy;
  • Patients with active infection requiring antibiotic treatment;
  • Uncontrolled hypertension, diabetes, and cardiovascular disease with obvious symptoms;
  • contrast agent allergy;
  • Women with pregnancy or lactation.

Treatment and study plan

BAI combine with DEB-BACE

Procedure
  • First treatment. Only infusion chemotherapy (THP + Platinum + Letitrexed), THP 20 ~30mg/m2, Nedaplatin 40mg/m2, Letitrexed 3mg/m2.
  • Second treatment. After infusionchemotherapy, EqualSpheres microsphere used for embolization: EqualSpheres microspheres (400 μm) 1tube was loaded and adsorbed THP (40 ~ 60mg/m2). End point of embolization: stagnation of blood flow in tumor feeding artery.

Primary outcomes

  1. PFS

    Time frame: up to 3 years

    PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.

Secondary outcomes

  1. ORR

    Time frame: up to 3 years

    ORR is defined as the percentages of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria

  2. Overall survival (OS)

    Time frame: up to 3 years

    The time from recruitment to death due to any cause.

Study contacts

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

Gang Wu, M.D

CONTACT

[email protected]

+8613938570175

Sponsors and collaborators

Lead sponsor

Gang Wu

Other

Registry information

Official study title

Efficacy and Safety of Bronchial Infusion Chemotherapy Combined With Drug-loaded Microsphere Embolization of EqualSpheres in the Treatment of Advanced Non-small Cell Lung Cancer

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Nov 13, 2023
Registry last updated
Nov 13, 2023

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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