Extensive-Stage Small-Cell Lung Cancer
Conditions
Interventions
Experimental Group:Hypofractionated Radiation Therapy in Stages Combined with Adebrelimab and Chemotherapy
Sponsors
HenanCancerHospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign the Informed Consent Form (ICF); 2. Aged 18 to 75 years old, regardless of gender; 3. Histologically or cytologically confirmed extensive-stage disease (AJCC [8th edition] Stage IV SCLC [any T, any N, and M1a/b/c]), or Stage T3-4 disease where the extensive range of multiple pulmonary nodules or the excessively large volume of the tumor/nodules makes it impossible to include them in a tolerable radiotherapy plan; 4. No prior systemic therapy has been received; 5. Within 4 weeks before enrollment, imaging evaluation (CT or MRI) confirms the presence of at least one measurable target lesion (in accordance with the RECIST v1.1 criteria); 6. The patient must be deemed suitable to receive thoracic radiotherapy as first-line treatment for extensive-stage small cell lung cancer (SCLC); 7. Within 4 weeks before enrollment, the Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0-2; 8. Estimated survival time >= 12 weeks; 9. The function of major organs must meet the following requirements:(1) Routine blood test: White blood cell count (WBC) >= 3.0 × 10?/L; Absolute neutrophil count (ANC) >= 1.5 × 10?/L; Platelet count (PLT) >= 100 × 10?/L; Hemoglobin (HGB) >= 9.0 g/dL (no supportive treatments such as blood transfusion or leukocyte elevation within 7 days); (2) Liver function: For patients without liver metastasis: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) = 50 mL/min (calculated using the Cockcroft/Gault formula); Urinary protein (UPRO) = 130 mmol/L before treatment; 10. Patients who are non-surgically sterilized or women of childbearing potential must undergo a serum pregnancy test within 7 days before the first dose of medication, with a negative result; and they must not be breastfeeding. Women of childbearing potential or male patients whose partners are of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 6 months after the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1. Has medical contraindications to etoposide-platinum (carboplatin or cisplatin)-based chemotherapy; 2. Has a history of thoracic radiotherapy before systemic treatment or plans to receive intensive thoracic radiotherapy. Radiotherapy for palliative purposes outside the chest (e.g., for bone metastases) is permitted, but it must be completed before the first administration of the study drug; 3. Concurrently receives any chemotherapy, biological products, or hormone therapy for cancer treatment. Hormone therapy used for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable; 4. Has undergone major surgery (as defined by the investigator) within 28 days before the first dose. Note: Local surgery for isolated lesions for palliative purposes is acceptable; 5. Has a history of allogeneic organ transplantation; 6. Has paraneoplastic syndrome (PNS) of autoimmune nature requiring systemic treatment (systemic steroids or immunosuppressants) or clinical symptoms indicating exacerbation of PNS; 7. Active or previously documented autoimmune disease or inflammatory disease (including inflammatory bowel disease [e.g., colitis or Crohn’s disease], diverticulitis [excluding diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener’s syndrome [granulomatosis with polyangiitis], Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc.); 8. Uncontrolled concurrent diseases, including but not limited to: persistent or active infection, interstitial lung disease, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, arrhythmia, severe chronic gastrointestinal disease with diarrhea, or psychiatric/social conditions that may limit compliance with study requirements, significantly increase the risk of adverse events (AE), or affect the subject’s ability to provide written informed consent; 9. Subjects with a history of or concurrent other malignant tumors within 5 years that require active treatment (except for fully treated tumors with an expected 5-year survival rate > 90%, such as basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and carcinoma in situ of the breast); 10. Subjects with clinically symptomatic/untreated central nervous system (CNS) metastases (e.g., brain, spinal cord) or leptomeningeal metastases; if screening imaging reveals active or new untreated CNS metastatic lesions, the subject will be excluded. (Exception: Eligibility is permitted if the subject is asymptomatic, or has received treatment with stable disease, and no imaging evidence of new CNS metastases or enlargement of existing CNS metastases is found for at least 2 weeks after the completion of brain metastasis treatment); 11. Patients with active autoimmune diseases or immunodeficiency, or with the following medical history, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc., are not eligible for inclusion. The following exceptions apply: patients with a history of autoimmune hypothyroidism who are receiving thyroid hormone replacement therapy may be included in the study. Type I diabetes patients whose blood sugar is well controlled through insulin administration regimens may participate in this study. 12. Active infections, including tuberculosis (clinical assessment, including clinical history, physical examination, imag
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;Overall survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactFangfang Gao
Henan Cancer Hospital
Outcome results
None listed