Non-small Cell Lung Cancer
Conditions
Interventions
Experimental Group:Radiotherapy+Tislelizumab+Paclitaxel liposome+Cisplatin
Experimental Group:radiotherapy+Tislelizumab+Pemetrexed+Cisplatin
control grop:Tislelizumab+Paclitaxel liposome+Cisplatin
control grop:Tislelizumab+Pemetrexed+Cisplatin
Sponsors
Yiyang Center Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients have fully understood the study, voluntarily participated in the study and signed the informed consent. 2. Ages 18 to 75, regardless of gender. 3. There were measurable lesions according to RECIST1.1 response evaluation criteria in solid tumors. 4. The pathological diagnosis is confirmed to be non-small cell lung cancer, and tumor tissue wax or sections less than 6 months old can be provided. 5. Stage IV non-small cell lung cancer. 6. Systemic use of immunosuppressive corticosteroids (prednisone >10mg/d or equivalent) was discontinued for at least 2 weeks before enrollment; 7. Good organ function: (1) Hematology: neutrophil absolute count (ANC) =1.5×109/L; Platelet =80×109/L; Hemoglobin =90g/L; (2) kidney: serum creatinine =1.5 times ULN or endogenous creatinine clearance =60mL/min (Cockcroft-Gault formula); (3) Liver: total bilirubin =1.5×ULN or for subjects with total bilirubin level >1.5×ULN, direct bilirubin is within the normal limit; AST and ALT 2.5 x ULN or less; (4) Endocrine system: Thyroid stimulating hormone (TSH) is within the normal range, or T3 and free T4 are within the normal range. (5) Coagulation function: International standardized ratio (INR) or prothrombin time (PT), activated partial thrombin time (APTT) =1.5×ULN, except for subjects receiving anticoagulant therapy, as long as PT or APTT is within the proposed use range of anticoagulant drugs; (6) Cardiac function test: Baseline electrocardiogram showed no prolongation of PR interval or atrioventricular block. 8. Women of childbearing age should agree to use contraception (such as an intrauterine device (IUD), birth control pills or condoms) during the study period and for a period of 6 months after the study ends; Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating; Men should agree to use contraception during the study and for six months after the end of the study period. 9. Expected survival is greater than 12 weeks
Exclusion criteria
Exclusion criteria: 1. People who are known to be allergic to immunotherapy ingredients; 2. Cancerous meningitis; 3. Those who are or have been diagnosed with active tuberculosis by chest radiography, sputum examination, or clinical examination; 4. Have a known or suspected active autoimmune disease; Exceptions: patients with a history of hypothyroidism, who do not require hormone therapy, or who are receiving physiological doses of hormone replacement therapy; Subjects with stable type 1 diabetes whose blood sugar is under control. 5. Hiv-positive persons or persons with acquired immune deficiency syndrome; 6. Comorbidities requiring immunosuppressive drugs; 7. A history of (non-infectious) pneumonia/interstitial lung disease requiring steroid treatment or a current history of pneumonia/interstitial lung disease requiring steroid treatment. 8. Use of immunosuppressive drugs within 2 weeks prior to initial study drug therapy, excluding topical or systemic corticosteroids not exceeding 10mg/ day of prednisone or equivalent doses of other corticosteroids; 9. Received live vaccine within 30 days prior to initial administration. This includes, but is not limited to, mumps, rubella, measles, varicella/shingles (chickenpox), yellow fever, rabies, BCG and typhoid vaccines (inactivated virus vaccines permitted). 10. Those who have used monoclonal antibody in the last 3 months, except for local application; 11. Those who have used Chinese herbal medicine to fight cancer in the past 2 weeks; 12. Patients with chronic hepatitis B or C (positive for HBV surface antigen or HCV antibody). 13. Active infections are known to require systemic treatment. 14. Prior malignancy (other than non-malignant melanoma skin cancer or carcinoma in situ of bladder, stomach, colon, endometrium, cervix, or breast), or these tumors had been cured for at least 2 years prior to enrollment and did not require additional antitumor therapy; 15. Patients with bleeding tendencies (e.g., active gi ulcers) or treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues. 16. Patients with any severe and/or uncontrolled disease, such as :(1) unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months prior to enrollment, and severe uncontrolled arrhythmia; Patients with poor blood pressure control (systolic >140 mmHg, diastolic >90 mmHg); (2) active or uncontrolled severe infection; (3) liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis; (4) Poor control of diabetes (FBG >10mmol/L); (5) patients with urine protein =++ and confirmed 24-hour urine protein quantity >1.0g in routine urine examination; (6) those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders; 17. Prisoners held illegally or compulsively for reasons other than mental or physical (e.g. infectious) diseases; 18. People who cannot tolerate venipuncture; 19. Pregnancy or breastfeeding; 20. Those who have used monoclonal antibody drugs within the last 4 weeks or who still have adverse reactions after using monoclonal antibody 4 weeks ago; 21. Anti-pd-1 or anti-PD-L1, anti-CTA4 and other antibodies have been used before. 22. Received radiotherapy within 6 months prior to initial treatment; 23. Drive gene positive patients who have not received targeted gene therapy; 24. Major surgery or massive blood transfusion (m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;Incidence of adverse reactions; | — |
Countries
China
Contacts
Public ContactLuo Long
Yiyang Center Hospital
Outcome results
None listed