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

Launched by THE CENTRAL HOSPITAL OF LISHUI CITY · Apr 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for small cell lung cancer (SCLC), a type of lung cancer. Researchers want to compare two treatment methods: one involves using a technique called bronchial arterial chemoembolization with drug-eluting beads (DEB-BACE) combined with a medication called serplulimab, while the other uses standard intravenous chemotherapy along with serplulimab. The goal is to see which treatment is more effective and safe for patients starting their cancer treatment.

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of SCLC at stages II to IV. You should also have a good performance status, meaning you can carry out daily activities with little difficulty. However, people with certain health issues, previous cancer treatments, or other serious conditions may not be eligible. If you join the study, you will receive one of the treatments and be monitored closely for any side effects and how well the treatment works. This trial is not yet recruiting, so there will be more details available once it begins.

Gender

ALL

Eligibility criteria

• 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.