Actively Recruiting
Establishment of a Prospective Clinical Cohort of Small Cell Lung Cancer Patients Receiving Radiotherapy-Involved Comprehensive Treatment
Led by Shanghai Chest Hospital · Updated on 2026-05-04
500
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
By establishing a prospective clinical cohort for small cell lung cancer (SCLC) and systematically collecting high-quality real-world data integrating clinical, imaging, pathological, and molecular dimensions, this study aims to enable personalized treatment for distinct SCLC subtypes. Furthermore, by evaluating the influence of radiotherapy timing, dose and fractionation, and target selection on efficacy and toxicity, we aim to identify the optimal radio-immunotherapy combination regimen that maximizes the synergistic effect in SCLC patients.
CONDITIONS
Official Title
Establishment of a Prospective Clinical Cohort of Small Cell Lung Cancer Patients Receiving Radiotherapy-Involved Comprehensive Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Histologically confirmed small cell lung cancer.
- Age 18 years or older.
- Life expectancy of at least 8 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 for limited-stage and 0 to 2 for extensive-stage.
- At least one measurable lesion and documented efficacy assessment.
- Adequate organ and bone marrow function based on recent laboratory tests.
- Pulmonary function with forced expiratory volume in 1 second (FEV1) greater than 0.75 L.
- No severe interstitial lung disease confirmed by CT or PET/CT.
- No prior or concurrent primary malignancy at other sites.
- For extensive-stage, patients with limited-stage SCLC who relapsed and are receiving immunotherapy for the first time may be included.
You will not qualify if you...
- Diagnosis of non-small cell lung cancer or pulmonary carcinoid.
- Missing efficacy assessment records.
- Presence of other primary malignancies or history of organ transplantation.
- Major surgery within 4 weeks before first dose.
- History of substance abuse, long-term alcoholism, AIDS or HIV.
- Active or history of autoimmune disease with risk of relapse.
- Current systemic corticosteroid or immunosuppressive therapy within 14 days before first dose.
- Prior treatment targeting immune checkpoints such as PD-1, PD-L1, CTLA-4, TIM-3, LAG-3.
- Interstitial lung disease or history requiring corticosteroids.
- History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or active pneumonitis on chest CT.
- Receipt of live vaccine within 28 days before first dose.
- Conditions contraindicating chemoradiotherapy including recent myocardial infarction, symptomatic heart disease, active infection.
- Unresolved toxicity grade 2 or higher.
- Pregnant or breastfeeding women; unwillingness to use contraception.
- Evidence of bleeding disorders.
- History of severe allergic reactions to antibodies or fusion proteins.
- Acute exacerbation of chronic pulmonary diseases requiring hospitalization.
- Prior progression after immunotherapy.
- History of autoimmune or immunodeficiency diseases including myasthenia gravis, lupus, rheumatoid arthritis.
- For extensive-stage, prior radiation limits current radiotherapy to metastatic lesions only.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
X
Xuwei Cai, Ph.D
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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