Small Cell Lung Cancer
Conditions
Interventions
Experimental group:Low-Dose Radiotherapy Combined with Etoposide, Cisplatin/Carboplatin, and Tislelizumab?
Sponsors
Shiyan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.At the time of screening, male or female subjects must be >= 18 years of age; 2.Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) (American Joint Committee on Cancer [AJCC] 8th Edition, Stage IV [any T, any N, M1a/b/c]) ??OR?? T3-4 disease with extensive pulmonary nodules or tumor/nodule size too large to be encompassed within a tolerable radiotherapy plan; 3.Patients must be considered suitable for first-line platinum-based chemotherapy for ES-SCLC. Chemotherapy must include etoposide in combination with either cisplatin or carboplatin; 4. ECOG 0–1; 5.??Life Expectancy:?? >= 3 months; 6. At least one measurable lesion according to RECIST 1.1 criteria; 7.No prior treatment for ES-SCLC. 8.Ability to provide written informed consent (ICF) and comply with study procedures and follow-up schedules. 9.Organ Function (within 7 days prior to treatment):????Hematology:??a) Hemoglobin (Hb) >= 90 g/L (no blood transfusion within 28 days);b) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; c) Platelet count (PLT) >= 80 × 10^9/L; d) White blood cell count (WBC) >= 3.5 × 10^9/L. ??Biochemistry:??a) Total bilirubin (TBIL) = 60 mL/min (Cockcroft-Gault formula); d) Left ventricular ejection fraction (LVEF) >= 50% (normal lower limit) by echocardiography; e) Coagulation: INR or PT <= 1.5 × ULN; 10.No prior exposure to immunomodulatory therapies, including anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies (except therapeutic antitumor vaccines); 11.Negative serum pregnancy test within 72 hours before study treatment initiation, and agreement to use effective contraception (e.g., intrauterine device, oral contraceptives, condoms) during the study and for 6 months after the last dose; Male Participants:?? Must agree to use appropriate contraception from the first dose until 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1.??Mixed SCLC and NSCLC?? (mixed small cell lung cancer and non-small cell lung cancer); 2.??Bone-related events??, including skeletal complications such as worsening bone pain or new bone pain, pathological fractures; 3.??Prior anti-tumor therapy within 4 weeks?? before study treatment initiation, including chemotherapy, molecular targeted therapy, radiotherapy, immunotherapy, monoclonal antibody therapy, or participation in other clinical trials of investigational drugs; 4.Known hypersensitivity?? to large-molecule protein preparations/monoclonal antibodies or any components of the investigational drugs; 5. Active autoimmune diseases?? requiring systemic treatment (e.g., corticosteroids or immunosuppressants) within the past 2 years (e.g., uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [asymptomatic hypothyroidism or hypothyroidism due to radiotherapy/chemotherapy may be allowed]; vitiligo or childhood asthma fully resolved without need for intervention in adulthood may be allowed); 6.Use of systemic corticosteroids (>= 10 mg/day prednisone-equivalent) or immunosuppressive medications within 14 days before enrollment or during the study; 7.Meningeal metastasis or symptomatic CNS metastases??; 8.??Live vaccination within 4 weeks?? before treatment initiation; 9.Prior anti-tumor vaccines?? or systemic immunostimulatory anti-tumor therapies; 10.Subjects with severe underlying medical conditions, including but not limited to:Severe infections;Uncontrolled diabetes;Cardiovascular diseases (e.g., NYHA Class III/IV heart failure, second-degree or higher heart block, myocardial infarction within the past 6 months, unstable arrhythmia or angina, or cerebral infarction within 3 months);Pulmonary diseases (e.g., interstitial pneumonia, obstructive lung disease, or symptomatic bronchospasm);Cerebrovascular events (including transient ischemic attack [TIA] or symptomatic pulmonary embolism); 11.??HBsAg and/or HBcAb positive with HBV DNA >10^3 copies/mL??, HCV antibody positive, or syphilis positive; 12.History of HIV infection?? or other acquired/primary immunodeficiency diseases; 13.History of autoimmune diseases??, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, idiopathic pneumonia, active tuberculosis, or findings suggestive of active pneumonia on chest CT (e.g., interstitial lung disease); 14.Other malignancies within the past 5 years??, except for cured in situ carcinomas or basal cell/squamous cell carcinoma of the skin; 15.Allogeneic hematopoietic stem cell transplantation or solid organ transplantation??; 16.Major surgery (except baseline tumor biopsy) or severe trauma within 4 weeks?? before study treatment initiation; 17.??Alcohol abuse, drug abuse, or substance dependence within the past year??; 18.History of neurological or psychiatric disorders?? (e.g., epilepsy, dementia) or poor compliance; 19.Other severe, acute, or chronic medical conditions or laboratory abnormalities?? that may increase study-related risks or interfere with interpretation of results; 20.Other reasons deemed unsuitable by the investigator??.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progerssion Free Survival, PFS;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Evaluation;Median Survival Time, mOS;Objective response rate, ORR; | — |
Countries
China
Contacts
Public ContactFengjun Cao
Shiyan People's Hospital
Outcome results
None listed