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| Name | Class |
|---|---|
| Shanghai Pulmonary Hospital, Shanghai, China | OTHER |
| Shanghai Chest Hospital of Shanghai Jiao Tong University | OTHER |
| Shanghai 10th People's Hospital | OTHER |
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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab (PD-L1 inhibitor) | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 12 months. |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult advanced SCLC patients who are eligible for receiving adebrelimab treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingnan Zhao, PhD | Contact | +86 (021)37798597 | zhaoqingnan2010@126.com | |
| Qian Xue, PhD | Contact | +86 (021)37798597 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Recruiting | Shanghai | 201620 | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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| Shanghai Zhongshan Hospital |
| OTHER |
| Huashan Hospital | OTHER |
| RenJi Hospital | OTHER |
| Shanghai Tongji Hospital, Tongji University School of Medicine | OTHER |
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Peripheral blood mononuclear cells, tumor tissue, lymph node tissue
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. |
| 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. | 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. | 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. | 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. | 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. | Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |