Efficacy and Safety of DEB-BACE Combined With PD-1 Inhibitors in Stage II/III NSCLC With Standard Treatment Failure

Wenzhou Medical University

Status: Not yet enrolling

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Procedure: Drug-eluting beads bronchial arterial chemoembolization; Drug: Programmed Cell Death Protein 1 Inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT05248022

ZJLS-KLDMIR-21002

Details and patient eligibility

About

This study is a prospective, multi-center, randomized, open-ended, double-arm clinical study. All eligible patients were randomly assigned to DEB-BACE combined with PD-1 inhibitor (Sindilizumab) treatment group (test group) and DEB-BACE treatment group (control group), to explore the efficacy and safety of combination therapy for stage II/III NSCLC with standard treatment failure or intolerable patients.

Enrollment: 98 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age more than 18 years old, no gender limit.
• According to the Diagnosis and Treatment of Primary Lung Cancer (2018 edition), non-small cell lung cancer (NSCLC) was diagnosed by histopathology.
• Tumor Node Metastasis (TNM) staging is II-III.
• According to the National Comprehensive Cancer Network (NCCN) guidelines, patients who had failed, refused, or were not suitable for standard treatment (surgery, chemoradiotherapy, targeted) after consultation.
• Eastern Cooperative Oncology Group (ECOG), Performance Status (PS) Score ≤ 2.
• Estimated survival time is more than 3 months.
• The patient has signed informed consent.

Exclusion criteria

• The patient has previously received interventional therapy [iodine seed implantation, ablation, bronchial arterial chemoembolization (BACE) therapy], or received immunotherapy during the first-line standard treatment.
• The patient is accompanied by other malignant tumors and had not been cured.
• White blood cell < 3×10*9/L, absolute value of neutrophils < 1.5×10*9/L, neutrophil/lymphocyte ratio ≥ 3, platelet count < 50×10*9/L, hemoglobin concentration < 90 g/L.
• Liver and kidney dysfunction (creatinine > 176.8 μmol/L; aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2 times the upper limit of normal).
• Uncorrectable coagulopathy or active hemoptysis.
• Patient with active infections requires antibiotic treatment.
• Patient has uncontrollable hypertension, diabetes, and cardiovascular disease with obvious symptoms.
• Allergy to contrast agents.
• Women with pregnancy or lactation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups

Combination Treatment Group

Experimental group

Description:

Drug-eluting Beads Bronchial Arterial Chemoembolization combined with Programmed Cell Death Protein 1 Inhibitor was used for treatment.

Treatment:

Drug: Programmed Cell Death Protein 1 Inhibitor

Procedure: Drug-eluting beads bronchial arterial chemoembolization

Single Treatment Group

Active Comparator group

Description:

Only receive drug-eluting beads bronchial arterial chemoembolization treatment.

Treatment:

Procedure: Drug-eluting beads bronchial arterial chemoembolization