small cell lung cancer
Conditions
Interventions
Adelbilimab combined with chemotherapy, sequential chest radiotherapy, and apatinib treatment group:After 4-6 cycles of adelbilimab+carboplatin+etoposide
Adelbilimab+chest radiation therapy (radiatio
Sponsors
Qingdao University Affiliated Qingdao Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range from 18 to 75 years old, both male and female; 2. Extensive small cell lung cancer confirmed by histology or cytology (according to the Veterans Administration Lung Study Group (VALG staging); 3. ECOG physical fitness score 0-1 points; 4. Have not received first-line systemic therapy or immune checkpoint inhibitors for ES-SCLC in the past; 5. Prior surgical treatment and adjuvant therapy with the goal of healing, such as radiotherapy and chemotherapy, with a minimum of 6 months of no treatment interval from the diagnosis of extensive SCLC to the last chemotherapy, radiotherapy or radiotherapy; 6. The presence of measurable lesions in the radiation field of the chest (iRECIST standard): A previously irradiated lesion can only be considered a measurable lesion if there is clear disease progression after radiation therapy and the previous lesion is not the only lesion; 7. Women of childbearing age must undergo a serum pregnancy study within 7 days before the first medication use, and the results should be negative. Female participants of childbearing age and male participants with partners of childbearing age must agree to contraception within 24 weeks after signing the informed consent form and the last administration of the study medication; 8.Before the first dose of the study drug, the laboratory test values meet the following conditions: (1) Blood routine (no blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days before screening): White blood cell count (WBC) = 3.0 × 109/L; Absolute neutrophil count (ANC) = 1.5 × 109/L; Platelet (PLT) = 100 × 109/L; Hemoglobin content (HGB) = 9.0 g/dL; (2) Liver function: Aspartate transaminase (AST) = 2.5 x ULN in subjects without liver metastasis; Alanine aminotransferase (ALT) = 2.5 x ULN, and ALT and AST = 5 x ULN in liver metastasis subjects; Total bilirubin (TBIL) in serum = 1.5 x ULN (excluding Gilbert syndrome with TBIL = 3.0 mg/dL); (3) Renal function: serum creatinine = 1.5 x ULN or creatinine clearance rate (CrCl) = 50 mL/minute (using Cockcroft/Fault formula, refer to Attachment 2); (4) Coagulation function: International normalized ratio (INR) = 1.5 x ULN, activated partial thromboplastin time (APTT) = 1.5 x ULN (only applicable to patients who have not received anticoagulant therapy currently, and patients who are currently receiving anticoagulant therapy should receive stable dose anticoagulant therapy); (5) Other: Lipase = 1.5 x ULN (if lipase>1.5 x ULN has no clinical or imaging confirmation of pancreatitis, it can be included in the group); Amylase = 1.5 x ULN (if amylase>1.5 x ULN has no clinical or imaging confirmation of pancreatitis, it can be included in the group); Alkaline phosphatase (ALP) = 2.5ULN, ALP = 5ULN in subjects with liver or bone metastasis; 9. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. During the screening period and previous imaging evaluations, it is expected that brain metastases cannot be controlled through radiotherapy; 2. Spinal cord compression that cannot be relieved by surgery and/or radiation therapy, or previously diagnosed spinal cord compression that has not been clinically proven stable for = 1 week before randomization after treatment; 3. Brain metastasis; 4. Third space effusion with clinical symptoms requires repeated drainage, such as pericardial effusion, pleural effusion, and abdominal effusion that cannot be controlled after pumping or other treatments; 5. Uncontrolled or symptomatic hypercalcemia; 6. Complicated with other malignant tumors = 5 years before the first dose, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery (hormone therapy for non metastatic prostate cancer or breast cancer is allowed); 7. Active, known or suspected autoimmune diseases (refer to Annex 4) include but are not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc. Type I diabetes (blood sugar can be controlled by insulin treatment), residual hypothyroidism caused by autoimmune thyroiditis that only requires hormone replacement therapy, or the condition that it is not expected to recur in the absence of external stimuli can be included in the group; Patients with eczema, psoriasis, chronic simple lichen, or only vitiligo skin disease manifestations (excluding psoriatic arthritis) who have a rash coverage area less than 10% of the body surface area, have the disease fully controlled at baseline and only require low efficacy local steroid treatment, If there has been no acute exacerbation of the underlying disease within the past 12 months (without the need for psoralen plus ultraviolet radiation [PUVA], methotrexate, retinoids, biological agents, oral calcineurin inhibitors, high potency or oral steroids), the study can be conducted; 8. Has 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-L1/2 inhibitors, or other drugs targeting T cells; 9. Use corticosteroids (>10 mg/day prednisone or equivalent dose) or other immunosuppressants within = 14 days before the first dose of the study drug. Allowing inhalation or local use of steroids and adrenal replacement steroids in the absence of active autoimmune diseases; 10. HBsAg positive and HBV DNA copy number greater than the upper limit of normal values in the laboratory of the research center (1000 copy number/ml or 500IU/ml), or HCV positive (HCV RNA or HCV Ab testing indicates acute or chronic infection); Known HIV positive medical history or known acquired immune deficiency syndrome (AIDS); 11. Have a history of idiopathic pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, radiation pneumonia requiring steroid treatment, or clinically active pneumonia; Or other moderate to severe lung diseases that seriously affect lung function (patients with a history of radiation pneumonia (fibrosis) in the radiation zone can participate in this study); 12. Subjects with active pulmonary tuberculosis (TB) or a history of active tuberculosis infection within = 48 weeks prior to sc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival;Survival rates at 1 and 2 years; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate evaluated by researchers;duration of response;Disease control rate evaluated by researchers;over-all survival;Progression free survival rates at 6 month and 1 year;The incidence and severity of adverse events (AE) and severe adverse events (SAE) evaluated based on CTCAE 5.0, as well as abnormal laboratory examination indicators;; | — |
Countries
China
Contacts
Public ContactXiaotao Zhang
Qingdao University Affiliated Qingdao Central Hospital
Outcome results
None listed