About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed extensive-stage small cell lung cancer;
Age ≥ 18 years;
The investigator determines that the patient is eligible for or is already receiving adebrelimab treatment.
Disqualifiers
Patients concurrently receiving other immune-modulating drugs or therapies;
Patients currently participating in other interventional studies;
Patients with concurrent other malignancies;
Patients with missing key study-related data.
Trial population
Adult advanced SCLC patients who are eligible for receiving adebrelimab treatment.
Trial design
Case-only
Prospective
Treatments tested in this trial
Adebrelimab (PD-L1 inhibitor)
Biological/VaccineInvestigating 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.
Treatment groups
Trial outcomes
Primary outcomes
Immune-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
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Collaborator
Shanghai Chest Hospital of Shanghai Jiao Tong University
Collaborator
Shanghai 10th People's Hospital
Collaborator
Shanghai Zhongshan Hospital
Collaborator
Huashan Hospital
Collaborator
RenJi Hospital
Collaborator
Shanghai Tongji Hospital, Tongji University School of Medicine
Collaborator