Small Cell LungCancer
Conditions
Interventions
Experimental group:Induction period: adebelimab (1200 mg, IV, Q3W, 4 treatment cycles) Apatinib 250 mg, oral, once a day Etoposide (100 mg/m^2, IV, Q3W, administered on the first day of each cycle, on
Maintenance period: adebelimab (1200 mg, IV, Q3W) Apatinib 250 mg, orally, once a day
Adebelimab is given on the first day of each cycle, and the dosing window can be /-3 days.
Sponsors
Nanjing Brain Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign the infom consent form (ICF); 2. Age>=18 years old, male or female; 3. Histologically or cytologically confirmed ES-SCLC; 4. Have not received systemic therapy for SCLC; 5. Have measurable lesions (RECIST 1.1); 6. Expected survival >=3 months; 7. The function of vital organs within 1 week before enrollment meets the following criteria: (1) blood routine: white blood cell (WBC) >=3.0 × 10^9/L; absolute neutrophil count (ANC) >=1.5 × 10^9/L; platelet (PLT) >=100 × 10^9/L; Hemoglobin (HGB) > = 9.0 g/dl (2) Liver function: aspartate transferase (AST) = 30.0 g/L (3) Renal function: serum creatinine = 50 mL/minute (using the Cockcroft/Gault formula) (4) Coagulation function: international normalized ratio (INR) 1.5 × ULN without clinical or imaging confirmation of pancreatitis, you can be enrolled; Amylase 1.5 × ULN is not clinically or radiographically confirmed for pancreatitis, it can be enrolled. Alkaline phosphatase (ALP) = 50% ; 8. Non-surgically sterile or female patients of childbearing potential must have a negative serum HCG test within 72 hours before the first dose and must be non-lactating, and must agree to use appropriate contraception (such as intrauterine device, contraceptive pill or condom, etc.) during the study treatment period and within 3 months after the end of the study treatment period; Male patients agree to use an appropriate method of contraception during the study treatment period and for 3 months after the end of the study treatment period.
Exclusion criteria
Exclusion criteria: 1. Toxicities due to prior anti-tumor therapy, other than alopecia and fatigue, did not recover to CTCAE 5.0 in females). = 470 ms) (4) clinically significant pericardial and myocardial disease; 5. Insufficient bone marrow reserve or organ function; 6. Treatment with systemic immunomodulators (including but not limited to thymus peptide, interferon or interleukin-2) within 4 weeks prior to enrollment; 7. Have any active autoimmune disease or history of autoimmune disease; Interstitial pneumonitis, drug-induced pneumonitis, radiation pneumonitis requiring steroid treatment, or clinically symptomatic active pneumonitis; 8. Active or uncontrolled severe infection (CTCAE 5.0 >=Grade 2) within 2 weeks prior to enrollment; 9. Patients with active or treated tuberculosis; 10. Uncontrolled hypertension (systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg), history of hypertensive crisis or hypertensive encephalopathy; 11. Intracranial hemorrhage known not related to the tumor; 12. Imaging (CT or MRI) shows that the tumor invades the large blood vessels or is not clearly demarcated from the blood vessels, or the investigator believes that there is a tendency to major bleeding, and the symptoms of hemoptysis or the daily hemoptysis volume is > within 3 months before screening=2.5 mL ; 13. Excessive arterior/venous thrombotic events within 24 weeks prior to enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; 14. Undergo invasive surgery within 4 weeks before admission; 15. Receiving drugs with bleeding tendency, such as aspirin (>325 mg/day), or treatment with full-dose oral or parenteral anticoagulants or thrombolytics 2 weeks prior to enrollment; 16. Hereditary bleeding tendencies or coagulation disorders. Clinically significant bleeding symptoms or diseases with clear bleeding tendency within 12 weeks prior to enrollment, such as gastrointestinal bleeding, positive fecal occult blood or vasculitis during the screening period; 17. History of the following within 24 weeks prior to enrollment: peptic ulcer, gastrointestinal perforation, corrosive esophagitis or gastritis, inflammatory bowel disease or diverticulitis, abdominal fistula, tracheo-esophageal fistula or intra-abdominal abscess, etc.; 18. Urine routine showed that urine protein >= ++, and confirmed that the 24-hour urine protein quantification was > 1.0 g; 19. HBsAg positive and HBV DNA test value exceeds the upper limit of normal reference value (1000 copy number/mL or 100 IU/m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival rate;Duration of Remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Overall Survival;Objective Response Rate;Disease Control Rate;12-month progression-free survival rate;12-month overall survival rate;18-month overall survival rate;Safety; | — |
Countries
China
Contacts
Public ContactHaitao Zhang
Nanjing Brain Hospital
Outcome results
None listed