Status:
COMPLETED
Prophylactic PEG-rhG-CSF During cCRT in LA-NSCLC
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Stage II-III Non-small Cell Lung Cancer
Concurrent Chemotherapy
Eligibility:
All Genders
18-80 years
Brief Summary
Objective: To evaluate the efficacy and safety of prophylactic use of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) during definitive concurrent chemoradiotherapy (cC...
Eligibility Criteria
Inclusion
- Diagnosis
- Histologically confirmed stage II-III non-small cell lung cancer (NSCLC)
- Treatment Plan
- Planned to receive concurrent platinum-based chemotherapy with radiotherapy (cCRT)
- Demographics
- Age 18-80 years
- Performance Status
- Karnofsky Performance Status (KPS) ≥70
- Organ Function
- Renal function: Creatinine clearance ≥60 mL/min
- Hepatic function: Total bilirubin ≤1.5×ULN, AST/ALT ≤2.5×ULN
- Absolute neutrophil count ≥2.0×10⁹/L
- Platelets ≥100×10⁹/L
- Hemoglobin ≥10 g/dL
Exclusion
- Active Malignancies
- Concurrent diagnosis of active malignancies (excluding: non-melanoma skin cancer, carcinoma in situ, or malignancies in complete remission for ≥5 years)
- Infectious/Immunological Conditions
- Active systemic infection requiring intravenous antimicrobial therapy
- Uncontrolled autoimmune diseases (defined as requiring systemic immunosuppressants at doses \>10 mg/day prednisone equivalent within 30 days prior to screening)
- Hypersensitivity Reactions
- Allergy to PEG-rhG-CSF or other biological products derived from genetically engineered Escherichia coli
- Neuropsychiatric Impairments
- Severe psychiatric disorders (e.g., schizophrenia, major depressive disorder with suicidal ideation) requiring hospitalization within 6 months)
- Prior Radiotherapy
- History of thoracic radiotherapy involving \>30% lung parenchyma or mean heart dose \>20 Gy
Key Trial Info
Start Date :
September 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 30 2025
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT06958614
Start Date
September 2 2019
End Date
January 30 2025
Last Update
May 6 2025
Active Locations (1)
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1
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China