Lung cancer
Conditions
Interventions
Observation Group:Adebelizumab (1200 mg, i.v., Q3W) + Apatinib (250 mg, p.o., QD) drug therapy
Sponsors
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. male or female patient, age =18 years; 2. ECOG physical fitness score 0-2 3. histologically or cytologically confirmed recurrent extensive stage small cell lung cancer (International Association for the Study of Lung Cancer (IASLC) 8th edition TNM staging criteria or VALG stage II), not suitable for localized treatment 4. progression after at least two lines of standard treatment regimens (at least one regimen consisting of platinum) 5. patients with at least one target lesion with a measurable radius according to the RECIST 1.1 criteria (tumor lesion with a long diameter of =10 mm on CT scan, lymph node lesion with a short diameter of =15 mm on CT scan, and a scan layer thickness of no more than 5 mm); 6. prior radiotherapy is permitted provided that the radiotherapy area is 10mg/day prednisone or equivalent dose) treatment within 2 weeks prior to enrollment; 10. Vital organ function within 1 week before enrollment meets the following criteria: (1) blood routine: white blood cell (WBC) = 3.0 × 109/L; absolute neutrophil count (ANC) = 1.5 × 109/L; platelet (PLT) = 100 × 109/L. (2) blood count = 1.5 × 109/L; platelets = 100 × 109/L; platelets = 100 × 109/L; platelets = 100 × 109/L. (3) no need to receive systemic corticosteroid hormone (>10 mg/day prednisone or equivalent dose within 2 weeks before enrollment. (2) Liver function: aspartate transferase (aspartate transferase, AST) = 2.5 × ULN, alanine aminotransferase (ALT) = 2.5 × ULN. ALT) = 2.5 × ULN, liver metastasis subjects with ALT and AST = 5 × ULN; serum total bilirubin (total bilirubin, TBIL) = 1.5 × ULN (except for Gilbert's syndrome = 3 × ULN); albumin (albumin, ALB) = 30.0 g/L. (3) renal function: serum creatinine = 1.5 × ULN or creatinine clearance rate. (3) Renal function: serum creatinine = 1.5 × ULN or creatinine clearance rate (CrCl) = 50 mL/minute (using the Cockcroft/Gault formula) (4) Coagulation function: international normalized ratio (INR) = 1.5, activated partial thromboplastin time (ACT) = 1.5, and activated partial thromboplastin time (APT) = 1.5, and activated partial thromboplastin time (APT) = 1.5. (4) Coagulation function: international normalized ratio (INR) = 1.5, activated partial thromboplastin time (APTT) = 1.5 × ULN (5) Others: lipase = 1.5 × ULN; if lipase > 1.5 × ULN without clinically or imaginatively proven pancreatitis, the patient can be enrolled; amylase = 1.5 × ULN; if amylase > 1.5 × ULN without clinically or imaginatively proven pancreatitis, the patient can be enrolled; and if the patient has no clinically or imaginatively proven pancreatitis, the patient
Exclusion criteria
Exclusion criteria: 1. patients with brain metastases, but patients with asymptomatic brain metastases may be enrolled; 2. patients with meningeal metastases; 3. patients diagnosed with active autoimmune diseases (congenital or acquired), such as interstitial pneumonitis (patients with vitiligo in complete remission are eligible for enrollment; patients with hypothyroidism and needing only hormone replacement therapy may be reenrolled; patients with type I diabetes mellitus may also be enrolled); 4. patients with bleeding tendency, including acute gastrointestinal bleeding, persistent bleeding disorders or coagulopathies 5. hypersensitivity to any component of the study drug; 6. Non-surgically sterilized or female patients of childbearing potential must have a negative serum HCG test within 72 hours prior to the first dose of study drug and must not be breastfeeding, and must agree to use appropriate contraception (e.g., intrauterine device, birth control pills, or condoms) during the study treatment period and for 3 months after the end of the study treatment period; male patients must agree to use appropriate contraception during the study treatment period and for 3 months after the end of the study treatment period. Male patients agree to use an appropriate method of contraception during and for 3 months after the end of study treatment; 7. Patients who are participating in other interventional studies; 8. Any other circumstances that, in the judgment of the investigator, make inclusion in the study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;AE; | — |
Countries
China
Contacts
Public ContactXin Zhao
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Outcome results
None listed