Lung Cancer
Conditions
Interventions
Test Group :tislelizumab combined with Bronchial arterial infusion chemotherapy
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients with stage ?B (T3-T4, N2) NSCLC confirmed by Histological or cytological examination (according to AJCC 8th edition) 2.ECOG PS0-1 3.More than 3 months Life expectancy 4. Absolute neutrophil count(ANC)=1.5 x 109/L, Platelet=100 x 109/L hemoglobin=90 g/L 5. International normalized ratio(INR)or Prothrombin time(PT)=1.5 X ULN 6. Activated partial thromboplastin time(aPTT)=1.5 x ULN 7. Total bilirubin=1.5 x ULN 8. Aspartate aminotransferase(AST)and alanine aminotransferase(ALT)=2.5 x ULN 9. Be able to understand written informed consent form(ICF) and agree to adhere to study requirements and evaluation schedules 10. Age 18-75 Male or female at the time of signing the ICF
Exclusion criteria
Exclusion criteria: 1. Patients received systemic anti-tumor therapy 2. Patients are known to carry EGFR, ALK and ROS-1 gene mutation or translocation 3.Patients received another approved systemic anti-tumor therapy or systemic immunomodulator 4 weeks prior to initial administration(Include but not limited to interferon, interleukin 2, and tumor necrosis factor) 4. Patient had active pia meningeal disease or brain metastases 5. Allergy to any investigational drug or excipient 6. Creatinine clearance <45mL/min 7. Patients who have been diagnosed by investigator with active viral hepatitis and need treatment 8. Patients with active autoimmune diseases and need systemic treatment, investigators evaluated patients who were considered to have impacts on study 9. Long-term heavy use of hormones or use of other immunosuppressant agents are assessed as having impacts on study therapy 10. Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis: a. Severe infections requiring hospitalization within 4 weeks prior to initial administration, including but not limited to complications from infection, bacteremia, or severe pneumonia, b. Oral or intravenous antibiotic therapy is given within 2 weeks prior to initial administration. 11. History of interstitial lung disease, noninfectious pneumonia, or uncontrolled systemic disease, including diabetes mellitus, hypertension, pulmonary fibrosis, acute lung disease, etc. 12. Any major surgery requiring general anesthesia was performed within 28 days or less prior to initial administration. 13. The presence of underlying medical conditions or alcohol/drug abuse or dependence that may not be conducive to study drug administration, or may affect the interpretation of results, or put patients at high risk for treatment complications. 14. Participating in another therapeutic clinical study at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event free survival;Disease free survival;Downstage Rate;Objective Response Rate;Surgery Rate;Overall Survival;Major Pathological Response; | — |
Countries
China
Contacts
Public ContactSen Jiang
Shanghai Pulmonary Hospital
Outcome results
None listed