The goal of this observational study is to evaluate the safety and efficacy of adebrelimab in the perioperative and advanced-stage treatment of small cell lung cancer （SCLC） under real-world conditions. The main questions it aims to answer are: 1. The safety of adebrelimab treatment in patients with advanced SCLC under real-world conditions, with a specific focus on the incidence of grade ≥3 immune-related adverse events. Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab. 2. Observe and evaluate the efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. This includes overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). Additionally, the study seeks to further explore the impact of patient baseline characteristics, such as brain metastases or liver metastases, and biomarkers on prognosis.
Study Type
OBSERVATIONAL
Enrollment
500
Investigating the efficacy and long-term safety of adebrelimab in different subgroups of SCLC patients (e.g., elderly patients, patients with comorbidities) in a real-world setting.
Shanghai General Hospital
Shanghai, China
RECRUITINGImmune-related adverse events
The incidence of grade ≥3 immune-related adverse events. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.
Overall survival (OS)
The efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. Record the survival （days） post first Adebrelimab Treatment.
Time frame: From enrollment to the end of treatment at 12 months.
Progression-free survival (PFS)
The efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. This includes progression-free survival (PFS) days post Adebrelimab treatment.
Time frame: From enrollment to the end of treatment at 12 months.]
Objective response rate (ORR)
The efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. This includes Objective response rate (ORR) post Adebrelimab treatment.
Time frame: From enrollment to the end of treatment at 12 months.
Disease control rate (DCR)
The efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. This includes Disease control rate (DCR) post Adebrelimab treatment.
Time frame: From enrollment to the end of treatment at 12 months.
The density of immune cells in peripheral blood before and after treatment
Although PD-L1 expression is currently a recognized predictive biomarker for efficacy, its predictive value varies significantly across different tumor types, detection platforms, and cutoff thresholds. Real-world data can be utilized through multi-omics integrated analysis (such as genomics, transcriptomics, and immune microenvironment characteristics) to identify novel biomarkers. We will measure immune cell density in peripheral blood before and after treatment, to determine whether they correlate with clinical response. This could provide a non-invasive approach for monitoring treatment efficacy.
Time frame: From enrollment to the end of treatment at 90 days.
Incidence of Adverse Events
The incidence of adverse events. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.
Incidence of Serious Adverse Events
The incidence of serious adverse events. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.
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