SCLC
Conditions
Interventions
Ivonescimab+EP+Radiotherapy:Ivonescimab 20mg/kg d1/q3w + EP d1/q3w. After 3 or 4 cycles of combined radiotherapy, the conventional segmentation mode is used, with a total dose of DT 50Gy/25F.
Sponsors
Taizhou People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written informed consent form 2. Age = 18 years old and = 75 years old. 3. The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) is 0 or 1. 4. Expected survival period = 6 months. 5. Histologically or cytologically confirmed, SCLC has not undergone prior anti-tumor treatments, including chemotherapy, radiotherapy, anti-angiogenic targeted therapy, and immunotherapy. 6.According to RECIST v1.1, there should be at least one measurable lesion that is suitable for repeated and accurate measurements; Brain metastases cannot be used as target lesions. 7. Determine good organ function through the following requirements (examination results within 14 days before starting the study treatment need to be provided): a) Hematology (did not use any blood components or cell growth factor support therapy within 7 days before starting the study treatment): i. Absolute neutrophil ANC = 1.5 × 109/L (1500/mm3) Ii. Platelet count = 100 × 109/L (100000/mm3) Iii. Hemoglobin = 90 g/L b) Kidney: i. Serum creatinine = 1.5 × ULN Ii. Urinary protein<2+or 24-hour (h) urinary protein quantification<1.0 g c) Liver: i. Serum total bilirubin (TBil) = 1.5 × ULN Ii. AST and ALT = 2.5 × ULN, for subjects with liver metastasis, AST and ALT can be = 5 × ULN Iii. Serum albumin (ALB) = 28 g/L d) Coagulation function: International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) = 1.5 × ULN e) Cardiac function: Left ventricular ejection fraction (LVEF) = 50% 8. Pulmonary function testing: normal or only mild ventilation dysfunction. Moderate ventilation dysfunction needs to be evaluated by researchers through multidisciplinary discussions before deciding whether to include in the study. 9.Female subjects with fertility must undergo a urine or serum pregnancy test (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test must be performed, based on the serum pregnancy result) within 3 days before the first use of medication, and the result must be negative. If a female subject with fertility has sexual intercourse with an unsterilized male partner, the subject must self screen and adopt an acceptable contraceptive method, and must agree to continue using the contraceptive method for 120 days after the last administration of the study drug; Whether to stop contraception after this point in time should be discussed with the researchers. 10. If an unsterilized male subject engages in sexual activity with a female partner who is capable of reproduction, the subject must use an effective contraceptive method from the start of screening until the 120th day after the last administration; Whether to stop contraception after this point in time should be discussed with the researchers. 11. The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study.
Exclusion criteria
Exclusion criteria: 1.Except for small cell lung cancer, the subjects had other malignant tumors within the 5 years prior to enrollment. Subjects with other malignant tumors that have been cured through local treatment are not excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ. 2. Simultaneously enroll in another clinical study, unless it is an observational, non interventional clinical study or a follow-up period of an interventional study. 3. Received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 used to treat thrombocytopenia) within 2 weeks before the first administration; Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications was received within 1 week before the first administration. 4. Previously received immunotherapy, including immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, and any other treatment targeting the tumor immune mechanism. 5. Previously received anti angiogenic therapy. 6.During the screening period, imaging showed that the tumor surrounded important blood vessels or had obvious necrosis or cavities, and the researcher determined that entering the study would pose a risk of bleeding. 7. Suffering from active autoimmune diseases that require systematic treatment within the past two years (such as treatment with disease improving drugs, corticosteroids, immunosuppressants). Alternative therapy (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a systemic treatment. 8. History of non infectious pneumonia/interstitial lung disease requiring systemic corticosteroid treatment or current presence of non infectious pneumonia. 9. There are metastases or compression in the brainstem, meninges, spinal cord. 10. Presence of active central nervous system (CNS) metastases; Subjects who have previously received treatment for brain metastases (such as surgery or radiation therapy) are allowed to be enrolled if they have been clinically stable for at least two weeks after treatment (calculated from the first administration of the study drug) and have stopped using corticosteroids 7 days before the administration of the study drug; Untreated and asymptomatic subjects with brain metastases (i.e. no neurological symptoms, no need for corticosteroids, no brain metastases with a length>1.5 cm, and no obvious edema around the brain metastases) can be enrolled. 11. Tumors invade important surrounding organs and blood vessels (such as the heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) or pose a risk of developing esophagotracheal fistula or esophageal pleural fistula. 12. Subjects with clinical symptoms or requiring drainage of pleural effusion, pericardial effusion, or ascites. 13. There are currently uncontrolled comorbidities, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or mental illnesses/social conditions that may limit subjects' compliance with study requirements or affect their ability to provide written informed consent. 14. History of myoc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;AE; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;DoR;TTR;PFS;1 or 2-year PFS rate; | — |
Countries
China
Contacts
Public ContactGaohua Han
Taizhou People's Hospital
Outcome results
None listed