Small cell lung cancer
Conditions
Interventions
Experimental Group:Adebrelimab combined with etoposide and platinum (Q3W, 4-6 cycles) ? adebrelimab combined with etoposide soft capsules (Q3W).
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Extensive-stage small cell lung cancer confirmed by pathology or cytology; 2. Age 18-75 years old, both sexes; 3. Expected survival more than 3 months; 4. ECOG score 0-1; 5. At least one measurable lesion according to RECIST 1.1 criteria; 6.no previous local or systemic treatment for small cell lung cancer; 7.Good major organ function, that is, the relevant examination indicators within 14 days before enrollment meet the following requirements: hemoglobin >= 90 g/L (no blood transfusion within 14 days); Neutrophil count > 1.5x10^9 /L; Platelet count >= 100x10^9/L; Total bilirubin =60 ml/min (Cockcroft-Gault formula); Left ventricular ejection fraction (LVEF) >= 50% was assessed by cardiac Doppler ultrasound. 8.Signed informed consent with good compliance, and family members agreed to cooperate with survival follow-up.
Exclusion criteria
Exclusion criteria: 1.History of other primary malignancies, with the exception of: a. malignancies treated with curative intent and free of known active disease =5 years prior to the first dose with a low potential risk of recurrence b. Adequately treated nonmelanoma skin cancer or lentigo maligna c with no evidence of disease. Adequately treated carcinoma in situ with no evidence of disease; 2.Participated in other drug clinical trials within four weeks; 3. Active or previously documented systemic immune disease or inflammatory disease (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [other than diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [e.g., granulomatous vasculitis, Gray's disease, rheumatoid arthritis, hypophysitis, and uveitis]). The following exceptions to this criterion are: a. patients with vitiligo or alopecia b. Patients with hypothyroidism whose condition is stable after hormone-replacement therapy (e.g., after Hashimoto's thyroiditis) c. Any patient with a chronic skin condition that does not require systemic treatment d. Patients who have been free of active disease for the last 5 years may be included, but only after consultation with the study physician e. People with celiac disease that can be controlled with diet alone; 4. Active hepatitis B (defined as screening hepatitis B surface antigen [HBSAg] test positive and HBV-DNA test value >= 2000 IU/ML) or hepatitis C (defined as screening hepatitis C surface antibody [HCsAb] test positive and HVC-RNA positive); 5. Uncontrollable complications, including but not limited to: "Persistent or active infection (other than HBV or HCV described above), symptomatic congestive heart failure, uncontrolled diabetes mellitus, uncontrolled hypertension, unstable angina, uncontrolled cardiac arrhythmias, active ID, severe chronic GI illness with diarrhea, or having a condition that may limit adherence to study requirements, result in a significantly increased risk of or be affected by AE. The ability of participants to provide written informed consent; 6.For female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment period; Serum or urine pregnancy tests had to be negative within 7 days prior to study enrollment, and they had to be nonlactating. Male subjects: patients who should be surgically sterilized or who agree to use a medically approved contraceptive during the study treatment period and for 6 months after the end of the study treatment period; 7.Have a history of immunodeficiency, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 8.Pleural or peritoneal effusion with clinical symptoms requiring clinical intervention; 9. Concomitant diseases that, according to the investigator's judgment, seriously endanger patient safety or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease Control Rate;Duration of Response; | — |
Countries
China
Contacts
Public ContactGuoren Zhou
Jiangsu Cancer Hospital
Outcome results
None listed