Brain metastases from non-small cell lung cancer
Conditions
Interventions
Sponsors
Shanxi Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age above 18 years old and below 75 years old, regardless of gender; 2.Patients with brain metastases from wild-type non-small cell lung cancer diagnosed histopathologically and histologically; 3.Expected survival >=3 months; 4.No intracranial radiotherapy; 5.ECOG score: 0-2; 6.No prior exposure to any anti-CTLA-4, anti-PD-1, anti-PD-L1 or anti-PD-L2 antibodies, except for therapeutic anticancer vaccines; 7.Major organs function normally, that is, meet the following criteria (no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factors to correct): (1)The standard of blood routine examination shall meet the following requirements: 1)HB 90 g/L or higher; 2)The ANC acuity 1.5 x 10^9/L; 3)PLT >= 80 x 10^9/L; (2)Biochemical examination shall meet the following standards: 1)TBIL 45 mL/min; 8.Women of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of apatinib; For men, surgical sterilization or consent to use appropriate methods of contraception during the observation period and for 8 weeks after the last administration of apatinib; 9.Patients voluntarily participated in this study and signed informed consent (ICF).
Exclusion criteria
Exclusion criteria: 1.Patients with meningeal metastasis; 2.Patients with brain metastasis accompanied by hemorrhage; 3.Patients with intracranial stroke; 4.Patients who have received radiation therapy to the brain; 5.Concurrent with other malignant tumors, except those that have been cured or whose disease is stable; 6.Patients who cannot tolerate radiation therapy due to any unstable systemic disease (including active infection, poorly controlled moderate to severe hypertension, unstable angina pectoris, congestive heart failure, liver and kidney disease, or metabolic disease); 7.Have any active autoimmune disease or a history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included if hormone replacement therapy is normal)); Patients with asthma who had vitiligo or had complete remission of asthma in childhood and did not need any intervention as adults were included, and those who required medical intervention with bronchodilators were not included; 8.Subjects who are required to take corticosteroid (> 10mg/day equivalent dose) or other immunosuppressant for systematic treatment within 14 days before the first use of the study drug; 9.The patient had a severe infection within four weeks prior to the first treatment; 10.Previous use of CTLA-4, PD-1 or PD-L1 inhibitors, CD137 agonists or anti-PD-L2; 11.The persistence of toxicity associated with previous chemotherapy and/or radiotherapy; 12.Allergic reaction to therapeutic drugs; 13.Radiological evidence (CT or MRI) indicating the presence of a cavitary or necrotizing tumor; 14.Radiological evidence (CT or MRI) of a central tumor with invasion of local large vessels; 15.Receive anticoagulant or antiplatelet medication; 16.Patients with abnormal coagulation function (INR > 1.5 x ULN, APTT > 1.5 x ULN) and bleeding tendency;Severe thrombus or clinically related severe bleeding events in the past 6 months; Clinically significant hemoptysis in the past 3 months;Predisposition to hereditary bleeding or thrombosis; 17.Patients with hypertension who cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure >140 mmHg, diastolic blood pressure > 90 mmHg); 18.Investigator judges other circumstances that may affect the determination of clinical study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial progression free survival; | — |
Countries
China
Contacts
Public ContactLi Hongwei
Shanxi Cancer Hospital
Outcome results
None listed