lung cancer
Conditions
Interventions
Experimental group:Adbelizumab + bevacizumab + chemotherapy
Sponsors
Meizhou People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The subjects voluntarily participated in the clinical research; 2.Male or female subjects aged 18-75 years old (including the critical value) at the time of signing the informed consent Form (ICF); 3.Subjects with stage IV non-squamous non-small cell lung cancer (nsqNSCLC) diagnosed by histopathological or cytological examination and accompanied by brain metastases; 4.The patient is required to provide a genetic test report. The genetic report should show negative driver genes, that is, no EFGR sensitive gene mutations and no ALK or ROS1 gene fusions; 5.MRI confirmed the metastasis of the tumor in the brain parenchyma, with >=3 brain lesions. Or patients with 1-2 brain lesions who are not suitable for local treatment or refuse local treatment. Among the brain lesions, there must be at least one measurable lesion with a diameter of >=5mm. Patients with local meningeal metastases are allowed, but those with extensive meningeal metastases are not included; 6.Asymptomatic brain metastases or brain metastases whose intracranial hypertension symptoms are controlled after dehydration treatment can continue medication at the time of enrollment or during the study to maintain stable symptoms; 7.Within 4 weeks before the first medication, at least one measurable target lesion was evaluated by the researchers according to RECIST v1.1; 8.If the patient does not have the result of the genetic test, they need to provide tumor tissues that meet the requirements for genetic testing; 9.The ECOG PS score is 0-1; 10.The expected survival period is >=12 weeks; 11.Good function of vital organs, that is, meeting the following criteria [No blood transfusion, albumin, recombinant human thrombopoietin or colony-stimulating factor (CSF) treatment was received within 14 days prior to the first administration of this study] : (1) Hematological system: Neutrophil (ANC) >=1.5×10^9/L; Platelet count (PLT) >=75×10^9/L; Hemoglobin (Hb) >=90g/L. (2) Liver function: Total bilirubin (TBIL) =30g/L; (3) the kidney function: creatinine (Cr) 1.5 x ULN or less; If >1.5×ULN, the creatinine clearance rate should be >=45mL/min (calculated according to the Cockcroft-Gault formula);(4) Coagulation function: Activated partial thromboplastin time (APTT) =2+, a 24-hour urine protein test is required. If the 24-hour urine protein is less than 1g, enrollment is allowed. 12.The serum pregnancy test of female subjects within 3 days before medication must be negative, and they agree to take effective contraceptive measures during the treatment and within 6 months after the treatment, and breastfeeding is prohibited during the treatment. Male patients need to agree to take contraceptive measures during the treatment period;
Exclusion criteria
Exclusion criteria: 1.It is known that there is a severe allergy history to any monoclonal antibody (NCI-CTCAE 5.0 grade greater than grade 3); Or it is known that there is a hypersensitivity reaction to the carboplatin/pemetrexed component; 2.Any active infection that requires systemic anti-infective treatment occurs within 7 days before the first administration; 3.Within 6 months prior to the first administration, there has been a history of myocardial infarction, poorly controlled arrhythmia (including QTc interval for males >= 450 ms and for females >= 470 ms) (QTc interval calculated using the Fridericia formula); or grade III-IV cardiac dysfunction according to the NYHA criteria or left ventricular ejection fraction =160/100 MMHG under the best hypertension treatment plan); 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial Progression-free Survival, iPFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress free survival,PFS;Adverse event;Intracranial objective response rate;Overall survival,OS; | — |
Countries
China
Contacts
Public ContactGuowu Wu
Meizhou People's Hospital
Outcome results
None listed