lungcancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meet the clinical research inclusion criteria; 2. Aged 18-75, regardless of gender; 3. Those who have clear consciousness, clear self-expression and no mental abnormality; 4. According to the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification 8th edition TNM staging, patients with locally advanced or metastatic NSCLC who are confirmed by histology or cytology and are inoperable and cannot receive radical concurrent chemoradiotherapy; 5. There is at least one reproducibly measurable tumor lesion according to RECIST1.1 standards; 6. Expected survival =3 months; 7. ECOG status score is 0-1 points; 8. Organ function levels must meet the following requirements: ? Hematological indicators: absolute neutrophil count =1.5×109/L, platelet count =80×109/L, hemoglobin =90g/L; ? Liver function: total bilirubin =1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase =2.5 times the upper limit of normal value, if there is intrahepatic transfer aminotransferase =5.0 times the upper limit of normal value; ? Renal function: creatinine =1.25 times the upper limit of normal, and creatinine clearance =60ml/min; ? Coagulation function: INR, PT and APTT = 1.5 times the upper limit of normal values; ? The electrocardiogram is basically normal. 9. Female subjects of childbearing age must undergo a serum pregnancy test and the result is negative, and are not in the lactation period. If they have sex with a non-sterilized male partner, they must take acceptable and effective measures from the beginning of screening to 120 days after the last dose. Contraceptive methods: Unsterilized male subjects who have sexual intercourse with female partners of childbearing age must use acceptable and effective contraceptive methods from the beginning of screening to 120 days after the last dose.
Exclusion criteria
Exclusion criteria: 1. Previous mental illness or family history; 2. Impaired consciousness and unable to cooperate with investigators; 3. Those who use psychotropic drugs; 4. Those who are unclear about their condition; 5. Multiple factors cause unclear language expression and self-care ability assessment is <90 points; 6. The subject has cancerous meningitis; 7. Subjects with active central nervous system (CNS) metastasis should be excluded. Subjects may participate in the study if their CNS metastasis can be adequately treated and if the subject's neurological symptoms return to baseline levels (other than residual signs or symptoms related to CNS treatment) at least 2 weeks before enrollment. In addition, subjects must be corticosteroid-naive or receiving a stable or tapering dose of =10 mg/day of prednisone (or equivalent); 8. Have coagulation disorder or bleeding tendency, or have a history of thrombosis or bleeding diseases; 9. There are unhealed wound ulcers or fractures; 10. Based on chest X-ray examination, sputum examination and clinical examination, it is determined that there is active tuberculosis (TB) infection. Patients with a history of active tuberculosis infection within the previous year must be excluded, even if they have been treated; patients with a history of active tuberculosis infection more than one year ago must also be excluded, unless it is proven that the course and type of anti-tuberculosis treatment previously used are adequate. appropriate; 11. People with existing severe heart disease, including: congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease and refractory hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anxiety, depression and sleep quality rating scale;Patient enrollment decision; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serological indicators; | — |
Countries
China
Contacts
Guangxi Medical University Cancer Hospital