Extensive-stage small-cell lung cancer with brain metastasis
Conditions
Interventions
Experimental Group:Adebrelimab Combined with Chemotherapy and Brain Radiotherapy
Sponsors
Henan Cancer Hospital
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 years or older, with no restriction on gender; 3. Histological or cytological confirmation of ES-SCLC (based on the second-stage staging method of the Veterans Lung Cancer Association (VALG) and the AJCC TNM staging method combined: Extensive stage: AJCC (8th edition) stage IV (any T, any N, M1a/b/c) or T3-4 due to multiple pulmonary nodules or large tumor/lesion volume that cannot be included in an acceptable radiotherapy plan); 4. ECOG PS:0-1; 5. Has not received any first-line systemic treatment for ES-SCLC in the past; 6. Within 4 weeks prior to enrollment, brain metastases were confirmed by imaging, with no limit on the number of metastases. The maximum diameter of the intracranial lesions was >= 0.5 cm. Brain metastases with clinical symptoms were allowed (requirements: intracranial hypertension could be controlled by dehydration treatment, and the symptoms did not further worsen within >= 3 days after the start of radiotherapy; dexamethasone treatment required = 12 weeks; 9. The functions of the vital organs should meet the following requirements: (1) Blood routine: White blood cell count (WBC) >= 3.0×10^9 /L; Absolute neutrophil count (ANC) >= 1.5×10^9 /L; Platelet count (PLT) >= 100×10^9 /L; Hemoglobin content (HGB) >= 9.0 g/dL (without corresponding blood transfusion, white blood cell elevation, etc. within 14 days); (2) Liver function: For patients without liver metastasis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 30g/L, alkaline phosphatase (ALP) = 50 mL/min (using Cockcroft/Gault formula); Urine protein (UPRO) 1.5 x ULN and there is no clinical or imaging evidence of pancreatitis, the patient can be enrolled. 10. For non-surgical sterilization or women of childbearing age, a serum pregnancy test must be conducted 7 days prior to the first administration of the drug, and the result must be negative; and they must be non-lactating. Male patients whose partner or the patient themselves is of childbearing age must agree to use an effective method of contraception during the study period and for the next 6 months after the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1. Have previously received any T-cell co-stimulation or immune checkpoint therapy, including but not limited to cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1 inhibitors, CD137 agonists, or other drugs targeting T-cells. 2. Patients who had previously received radiotherapy and chemotherapy for limited-stage small cell lung cancer, and patients with brain metastases from primary cancer; 3. Subjects with clinical symptoms of leptomeningeal metastasis; 4. The tumor was histologically or cytologically confirmed to contain components of non-small cell lung cancer, large cell neuroendocrine carcinoma, or sarcomatous lesions; 5. Within 2 years prior to the first administration, there has been a case of active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants), or a history of autoimmune disease with a predicted recurrence. Alternative therapies (such as thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment; 6. Diagnosed with immunodeficiency or having received systemic glucocorticoid therapy within 14 days prior to the first administration of the study drug, or undergoing any other form of immunosuppressive therapy; Allowed to use a physiological dose of glucocorticoids (= 10mg/day of prednisone or equivalent). 7. Those who have experienced thrombotic events (such as cerebrovascular accidents including transient ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis, or pulmonary embolism within 6 months prior to the first administration; 8. Has a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), drug-induced pneumonia or idiopathic pneumonia; or the chest computed tomography (CT) scan at screening shows evidence of active pneumonia (patients with active tuberculosis cannot be enrolled); 9. Within 28 days prior to the first administration, had undergone major surgical treatment or suffered from significant traumatic injury; 10. Within 4 weeks prior to the first administration, had received or planned to receive prophylactic vaccines or attenuated live vaccines; 11. Within the four weeks prior to signing the ICF, had received any other investigational drug treatment or participated in another interventional clinical study; 12. Within 5 years, the subject has a history of or concurrently suffers from other malignant tumors that require active treatment (except for those that have been fully treated 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, localized prostate cancer after radical resection, localized bladder cancer, ductal carcinoma in situ after radical resection, and carcinoma in situ of the breast). 13. Findings from Physical Examination and Laboratory Tests Subjects with any severe and/or uncontrolled diseases, including:a) Unwell-controlled clinical symptoms or diseases of the heart, such as: >= Grade 2 myocardial ischemia or myocardial infarction, uncontrollable arrhythmia (including QTc >= 450ms in males and QTc >= 470ms in females), >= Grade 2 congestive heart failure (New York Heart Association [NYHA] classification), unstable angina pectoris, myocardial infarction occurring within 24 weeks, or clinically significant supraventricular or ventricular ar
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Objective Response Rate, ORR;Disease Control Rate, DCR;iORR;Overall Survival, OS;iPFS; | — |
Countries
China
Contacts
Public ContactChen Lijuan
Henan Cancer Hospital
Outcome results
None listed