squamous NSCLC
Conditions
Interventions
experimental group:Albumin-bound paclitaxel + Anlotinib + Camrelizumab
Control group:Albumin-bound paclitaxel +Platinum
Sponsors
Hubei Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. ECOG PS 0-1, life expectancy exceeds 3 months; 3. Histological or cytological pathology confirmed as squamous non-small cell lung cancer; 4. Researchers confirm that there is at least one measurable lesion according to the RECIST 1.1 standard; 5. According to the 8th edition of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification, TNM staging is IIIB-IV or recurrence. For locally advanced disease, it is necessary to prove that it cannot be operated and cannot receive radical concurrent radiotherapy and chemotherapy; 6. Genetic testing showed that EGFR and ALK driver genes were negative; 7. The main organs function well. Blood routine absolute neutrophil count>=1.5x10^9/L, platelet count>=100x10^9/L, erythropoietin>=90 g/L. Liver function total bilirubin level = 60 ml/min (Cockcroft-Gault formula); routine urinalysis is less than 2+ urine protein, or 24-hour urine protein quantification <1 g . The international normalized ratio of coagulation function (INR) or prothrombin time (PT) <= 1.5 times ULN; if the subject is receiving anticoagulant therapy, the PT is within the expected use range of anticoagulant; 8. If there is a risk of conception, implement effective contraception for both male and female patients (that is, a method with a failure rate of less than 1% per year).
Exclusion criteria
Exclusion criteria: 1. Pathological examination of squamous or small cell lung cancer or adenocarcinoma component mixture; 2. Previously treated with anti-PD-1 or anti-PD-L1 antibodies or drugs that stimulate or synergistically inhibit another T cell receptor; 3. Carry out anti-tumor systemic treatment with traditional Chinese medicine or immunomodulators within 2 weeks before the first administration; 4. Complete palliative radiotherapy within 7 days before the first administration; 5. There are clinically active brain metastases; 6. There is clinically uncontrollable pleural effusion/abdominal effusion; 7. Active autoimmune diseases that require systemic treatment; 8. History of hemoptysis; 9. History of abdominal fistula, gastrointestinal perforation or abdominal abscess; 10.Have a history of myocardial infarction or stroke within 6 months before enrollment; 11. The wound does not heal, active peptic ulcer or fracture; Have a history of abdominal fistula, tracheoesophageal fistula or other grade 4 fistula, gastrointestinal perforation or intra-abdominal abscess within 12.6 months; 13. Medical history or genetic tendency of bleeding or coagulopathy; 14. Need to receive anticoagulant therapy; 15. Arterial or venous thromboembolism occurred within 6 months before study entry; 16. Poorly controlled arterial hypertension (systolic blood pressure>150 mmHg and/or diastolic blood pressure>100 mmHg); 17. Pregnancy or breastfeeding; 18. Diagnose other malignant tumors within 5 years before the first administration, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after radical resection; 19. Known to have mental illness or drug abuse that may affect compliance with the test requirements; 20. Vaccine live vaccine within 30 days before the first injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficient;Survival time;Disease control rate;Duration of relief; | — |
Countries
China
Contacts
Public ContactHu Sheng
Hubei Cancer Hospital
Outcome results
None listed