Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC

Wenzhou Medical University

Status

Not yet enrolling

Conditions

Small Cell Lung Cancer

Carcinoma

Treatments

Procedure: Intravenous chemotherapy

Procedure: Drug-eluting beads bronchial arterial chemoembolization

Drug: Serplulimab

Study type

Interventional

Funder types

Other

Identifiers

NCT06364046

ZJLS-KLDMIR-22006

Details and patient eligibility

About

This project aims to conduct a prospective, single-center, randomized, open-label, two-arm study to compare the clinical efficacy and safety of bronchial arterial chemoembolization with drug-eluting beads (DEB-BACE) combined with serplulimab versus conventional intravenous chemotherapy combined with Serplulimab as first-line treatment for SCLC patients. The objective is to provide evidence-based support for clinical practice.

Enrollment

56 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age more than 18 years old, regardless of gender;
SCLC diagnosis based on histopathology according to the Primary Lung Cancer Diagnosis and Treatment Guidelines (2018 edition);
TNM stage II-IV;
ECOG PS score ≤2;
Predicted survival time more than 3 months;
Provision of signed informed consent.

Exclusion criteria

Previous interventional therapies such as iodine seed implantation (within the past six months), ablation, BACE, or immunotherapy;
Concurrent presence of other incurable malignant tumors;
White blood cell count less than 3×10^9/L, neutrophil absolute count less than 1.5×10^9/L, neutrophil/lymphocyte ratio equal to or greater than 3, platelet count less than 50×10^9/L, hemoglobin concentration less than 90 g/L;
Hepatic and renal insufficiency (creatinine level exceeding 176.8μmol/L); Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels more than twice the upper limit of normal;
Uncorrectable coagulopathy or concurrent active hemoptysis;
Complicated with active infection requiring antibiotic treatment;
Uncontrolled hypertension, diabetes, or cardiovascular disease;
Allergy to contrast agents;
Women who are pregnant or lactating.