A Real-World Study Evaluating the Efficacy and Safety of Adebrelimab in Patients With Advanced SCLC

Официальное название

A Real-world Study on the Efficacy and Safety of Adebrelimab in the Treatment of Advanced-stage Small Cell Lung Cancer

Обзор

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.

Вмешательства

• Биопрепарат Adebrelimab (PD-L1 inhibitor)
  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.

Первичные конечные точки

• Immune-related adverse events [Срок оценки: Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.]

Вторичные конечные точки (7)

• Overall survival (OS) [Срок оценки: From enrollment to the end of treatment at 12 months.]
• Progression-free survival (PFS) [Срок оценки: From enrollment to the end of treatment at 12 months.]]
• Objective response rate (ORR) [Срок оценки: From enrollment to the end of treatment at 12 months.]
• Disease control rate (DCR) [Срок оценки: From enrollment to the end of treatment at 12 months.]
• The density of immune cells in peripheral blood before and after treatment [Срок оценки: From enrollment to the end of treatment at 90 days.]
• Incidence of Adverse Events [Срок оценки: 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 [Срок оценки: Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Китай · 1 центр

• Shanghai General Hospital — Шанхай

Идентификаторы

NCT: NCT07434518 · 20250704064933814

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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