Non-small cell lung cancer (NSCLC)
Conditions
Interventions
Treatment group:Neoadjuvant chemotherapy combined with tislelizumab immunotherapy, concurrent with SBRT and low-dose mediastinal radiotherapy
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1.The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up; 2.18Age =1.5×10^9/L; PLT>=100×10^9 HB>=90g/L Biochemical tests must meet the following standards: TBIL=50mL/min (Cockcroft-Gault formula); ALB>=30g/L The coagulation function must meet the following requirements: INR 60%; FEV1 > 1.2L, FEV1% > 40%; DLco>40%.
Exclusion criteria
Exclusion criteria: 1.Suffering from congenital or acquired immune dysfunction, such as being infected with the Human Immunodeficiency Virus (HIV), active hepatitis B, hepatitis C, or co-infection with both hepatitis B and hepatitis C; 2.Immunosuppressive drugs have been used within 14 days before the first use of the study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e., no more than 10mg/ day prednisone or its equivalent drugs); 3.The patient's weight loss was >=10% within 6 months before enrollment, or BMI was =140mmHg or diastolic blood pressure >=90mmHg, despite the best drug treatment); Those newly diagnosed with angina pectoris within 3 months before screening or those who experienced myocardial infarction events within 6 months before screening; Arrhythmia (including QTcF: >=450ms for men, >=470ms for women) requires long-term use of antiarrhythmic drugs and cardiac insufficiency classified as >= grade II by the New York Heart Association; 7.Those with a history of severe lung or heart diseases; 8.Severe concurrent infection (such as: requiring intravenous infusion of antibiotics, antifungal or antiviral drugs) within 4 weeks before the first administration, or having a fever of unknown cause >38.5? during the screening period/before the first administration; 9.Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 10.Pregnant or lactating women; Patients with fertility who are unwilling or unable to take effective contraceptive measures; 11.It is known that allergic reactions, hypersensitivity reactions or intolerances may occur to the test drug and its excipients. 12.Subjects who are participating in other clinical studies or whose first medication time is less than 4 weeks from the end of the previous clinical study (the last medication), or the 5 half-lives of the drug in this study; 13.The subjects are known to have a history of psychotropic drug abuse, alcohol abuse or drug abuse. 14.The researcher believes that there is any situation that may harm the subjects or cause them to be unable to meet or carry out the research requirements; 15.After neoadjuvant therapy, the patient cannot tolerate surgery or is not suitable for surgery due to the progression of the disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate (pCR); | — |
Countries
China
Contacts
Public ContactQifei Wu
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed