NCT07434518
Recruiting
Not Applicable
A Real-world Study on the Efficacy and Safety of Adebrelimab in the Treatment of Advanced-stage Small Cell Lung Cancer
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine1 site in 1 country500 target enrollmentStarted: January 27, 2026Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Immune-related adverse events
Overview
Brief Summary
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:
- 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.
- 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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Immune-related adverse events
Time Frame: Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.
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)(From enrollment to the end of treatment at 12 months.)
- Progression-free survival (PFS)(From enrollment to the end of treatment at 12 months.])
- Objective response rate (ORR)(From enrollment to the end of treatment at 12 months.)
- Disease control rate (DCR)(From enrollment to the end of treatment at 12 months.)
- The density of immune cells in peripheral blood before and after treatment(From enrollment to the end of treatment at 90 days.)
- Incidence of Adverse Events(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(Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.)
Investigators
Zheng Ruan
Dr./Chief Physician, Thoracic Surgery
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study Sites (1)
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