Initial treatment of patients with extensive small cell lung cancer
Conditions
Interventions
Experimental group:Adebrelimab+carboplatin+etoposide+radiotherapy
Sponsors
Hunan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years old; 2. The physical status of the American Eastern Cancer Consortium (ECOG) was 0 or 1; 3. Patients with extensive stage ES-SCLC confirmed by histology or cytology; 4. The presence of at least one measurable lesion assessed according to the RECIST v1.1 criteria; 5. Life expectancy is more than 3 months; 6. Have not received systemic anti-tumor therapy before; 7. Adequate organ function: 1) Bone marrow function: absolute neutrophil count =1.5×10^9 /L, platelet count =90 ×10^9 /L, hemoglobin =90g/L; 2) Liver function: defined as total bilirubin level =1.5 times the upper limit of normal (ULN); In patients without liver metastasis, the levels of glutamic oxalic aminotransferase (AST) and glutamic pyruvic aminotransferase (ALT) were less than 3 times ULN; For patients with recorded liver metastasis, AST and ALT levels were =5 ULN; 3) Renal function: defined as serum creatinine =1.5 times ULN; Urine protein is less than 2+ for routine urine examination. If the patient has urine protein =2+ at baseline level, 24-hour urine should be collected and 24-hour urine protein quantitative detection =1g should be demonstrated. 4) Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) =1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as PT is within the intended range of anticoagulant drug use; 8. For female subjects of reproductive age, urine or serum pregnancy tests should be negative within 7 days prior to receiving the first study drug administration (cycle 1, day 1). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is required; For men, consent to use appropriate methods of contraception or surgical sterilization during the trial period and within 8 weeks after the last dose of the trial drug; 9. Able to comply with research and follow-up procedures; 10.Sign written informed consent before any trial related procedures are implemented.
Exclusion criteria
Exclusion criteria: 1. Allergic to the experimental drug; 2. Is currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to initial dosing; 3. Prior treatment with any T cell co-stimulation or immune checkpoint, including but not limited to cytotoxic Tlymphocyte-associated antigen-4, CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other drugs that target T cells; 4. Symptomatic brain metastases; 5. Patients with untreated or active progressive central nervous system (CNS) metastases who are treated for CNS lesions and are asymptomatic are eligible to participate in this study if they meet all of the following criteria: 1) Measurable lesions that meet the definition of RECISTv1.1 exist outside the CNS; 2) The patient had no history of intracranial or spinal hemorrhage; 3) The patient had not received stereotactic radiation therapy within 7 days before the start of study therapy, whole-brain radiation therapy within 14 days before the start of study therapy, or neurosurgical resection within 28 days before the start of study therapy; 4) Patients do not require ongoing corticosteroid treatment for CNS disease. Acceptance of stable doses of anticonvulsant drugs; 5) Metastasis is limited to the cerebellar or supratentorial areas (i.e. not to the midbrain, pons, medulla oblongata, or spinal cord); 6. Received solid organ or blood system transplantation; 7. Third space effusion with clinical symptoms requires repeated drainage, such as pericardial effusion, pleural effusion and abdominal effusion that cannot be controlled by pumping or other treatment; 8. Poorly controlled tumor-related pain: ? 1) Patients in need of analgesics had a stable analgesic treatment regimen at the time of enrollment in this study; 2) For lesions that are symptomatic and acceptable for palliative radiotherapy (such as bone metastases or metastases that cause nerve compression), treatment should be completed before enrollment. Patients should recover from the effects of radiation therapy. No minimum recovery period is required; 3) Local treatment of metastases that are currently asymptomatic but may lead to functional impairment or intractable pain with further growth (e.g., epidural metastases not currently associated with spinal cord compression) should be considered before enrollment, as appropriate; 9. Poorly controlled or symptomatic hypercalcemia (ionic calcium >1.5mmol/L, calcium >12mg/dL or corrected calcium) More than ULN); 10. Had any medical condition requiring systemic treatment with corticosteroids (prednisone or equivalent at a daily dose of > 10 mg) or other immunosuppressive agents during the 14 days prior to randomization; 11. A history of active autoimmune disease or autoimmune disease that may recur; 12. Evidence of a history of idiopathic pulmonary fibrosis, organic pneumonia (e.g., bronchiolitis obliterans), or noninfectious pneumonia on chest CT scans performed during the screening period; 13. A history of serious infections in the 4 weeks prior to randomization, including but not limited to hospitalization for infectious complications, bacteremia, or severe pneumonia; 14. Severe chronic or active infections (including tuberculosis infections, etc.) requiring systemic (oral or intravenous) antibiotic treatment within 14 days prior to randomization; 15. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); Untreate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| mPFS;OS;DOR;DCR;The relationship between the expression of four transcription factor subtypes of SCLC-A/N/P/I, PD-L1, and therapeutic efficacy; | — |
Countries
China
Contacts
Public ContactLi Xu
Hunan Cancer Hospital
Outcome results
None listed