Non-small cell lung cancer
Conditions
Interventions
experimental group :Neoadjuvant hypofractionated ablative brachytherapy combined with PD-1 blockade plus surgery
Sponsors
Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Preoperative histology confirmed as NSCLC, after the systemic examination, the initial staged patients with stage IIB-IIIB (according to the eighth edition of international lung cancer TNM staging); multidisciplinary team assessment; 2. Patients > 18 years old, = 1.2 liters / sec or >= 50% predicted value, postoperative expectation (FEV1) >= 30%; 7. No history of chemotherapy or other immunosuppressive therapy in February; 8. The following laboratory tests performed within 7 days prior to the first dose confirmed that the patient's bone marrow, liver and kidney function met the requirements of the study: - hemoglobin >= 9.0 g / dL (can be maintained or exceeded by blood transfusion); - Red blood cell count >= 2.0 * 10^9 / L - absolute neutrophil count (ANC) >= 1.0 * 10^9 / L; - platelet count >= 100 * 10^9 / L; - total bilirubin is within normal limits; - alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase = 60ml / min; - Patients who have not received anticoagulant therapy have an international normalized ratio of prothrombin time (INR) <= 1.5 and partial thromboplastin time (APTT) <= 1.5 times the upper limit of normal. Patients receiving total or parenteral anticoagulant therapy may be stable for at least 2 weeks before entering the clinical study, and the results of the coagulation test may be entered into clinical trials within the limits of local treatment; 9. Women of childbearing age test urine and serum HCG within 7 days before the start of treatment, and the results need to be negative; male and female patients of appropriate age must use a reliable method of contraception before entering the test, and until 30 days after stopping the drug. A reliable method of contraception will be determined by the primary investigator or designated person.
Exclusion criteria
Exclusion criteria: 1. Any unstable systemic disease (including active infections, uncontrolled high blood pressure, unstable angina, angina pectoris that has started within the last 3 months, congestive heart failure ( >= New York Heart Association, NYHA) , grade II), cardiac infarction (6 months before enrollment), severe arrhythmia requiring medication, liver, kidney or metabolic disease; 2.2 combined with uncontrolled neuropathy (grade 2 or above) or psychotic patients; 2. The previous treatment for NSCLC (including cytotoxic drug therapy, targeted therapy, immunotherapy, surgery and local radiotherapy) elution time > 2 months; 3. Direct infiltration of the lungs: mediastinum, heart, large blood vessels, trachea, esophagus, carina, malignant chest; 4. Pregnant or lactating women; 5. Patients who have undergone major surgery or severe trauma within 2 months prior to the first dose; 6. Systemic infections requiring treatment, autoimmune diseases, past or current detection of human immunodeficiency virus (HIV) or AIDS; 7. Allergic to research drugs; 8. Other investigators believe that it is not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;Pathological remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival;5-year overall survival;Relapse Rate; | — |
Countries
China
Contacts
Public ContactSheng Lin
Department of Oncology, Affiliated Hospital of Southwest Medical University
Outcome results
None listed