non-small cell lung cancer
Conditions
Interventions
Experimental group:Neoadjuvant + surgery + postoperative adjuvant
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 and =1.5L, or expected post-lobectomy/pneumonectomy FEV1 >=800 mL, meeting the surgical requirements for curative-intent treatment; 10. Adequate organ function, including: (1) Bone marrow: Absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, hemoglobin >= 90 g/L; (2) Liver: Total bilirubin = 45 mL/min (using standard Cockcroft-Gault formula); (4) Coagulation: For patients not on anticoagulants, INR <= 1.5 and APTT <= 1.5 x ULN. Patients receiving full-dose or parenteral anticoagulant therapy are eligible if the anticoagulant dose has been stable for at least 2 weeks prior to study entry and coagulation test results are within the institution's acceptable range; (5) Women of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to first study drug administration and agree to use medically approved, effective contraception (e.g., intrauterine device, contraceptive devices, or condoms) during the study and for 3 months after the last study drug administration.
Exclusion criteria
Exclusion criteria: 1.The patient has received any systemic anti-tumor treatment in the past, including cytotoxic drug therapy, immunotherapy, radiotherapy, experimental treatment, etc. 2. Previously treated with immune checkpoint inhibitors such as anti-PD-1, PD-L1 or CTLA-4, anlotinib and other anti-angiogenic drugs, chemotherapy drugs, etc. 3. Known to carry epidermal growth factor receptor (EGFR) mutations or ALK gene translocations; For patients with non-squamous cell carcinoma, EGFR test results and ALK test results based on tumor tissue must be provided. For patients with squamous non-small cell lung cancer, if the EGFR mutation status and ALK mutation status are unknown, it is not required to conduct tests during screening. 4. There are multiple factors affecting patients taking oral medication (such as inability to swallow, chronic diarrhea, intestinal obstruction); 5. Allergy to any research drugs (tislelizumab, anlotinib, albumin-bound paclitaxel) or excipients; 6. Imaging studies show that the tumor has invaded the area around important blood vessels, or researchers determine during the treatment process that the possibility of the patient's tumor invading important blood vessels and causing fatal bleeding is relatively high. 7. Within 3 months prior to the study, there was clinically significant hemoptysis (more than 50ml of hemoptysis per day), or there were clinically significant bleeding symptoms or obvious bleeding tendencies (such as gastrointestinal bleeding, gastric ulcer bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ or above baseline, or having vasculitis, etc.); 8. Live attenuated vaccines should be administered within 4 weeks before the first vaccination or during the study period. 9. Patients who are expected to be intolerant to surgery, such as those with heart and lung insufficiency; 10. Other malignant tumors that have occurred or are currently concurrently present within the past five years, excluding cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invading the basement membrane)]; 11. Patients with active viral hepatitis identified by researchers as requiring treatment: (1) Chronic hepatitis B virus carriers with HBV DNA >=500 IU/mL (2500 copies/mL) (HBV DNA testing is only performed for patients who test positive for hepatitis B core antibody ); (2) Patients who test positive for HCV RNA (HCV RNA testing is only performed for patients who are positive for hepatitis C virus antibodies); 12. Patients with active autoimmune diseases that require systemic treatment, or those who have been using hormones or other immunomodulators in large quantities for a long time, and whom the researchers assess as having an impact on the study treatment; 13. There were unhealed surgical incisions before the start of the study treatment (small biopsy incisions could be included); 14. Have active hepatitis B/C infection and human immunodeficiency virus (HIV) infection; 15. Within 6 months, there have been arterial or venous thrombotic events (such as cerebrovascular accidents, deep vein thrombosis, pulmonary embolism, etc.) or severe cardiovascular diseases: grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia; According to the NYHA standard, patients with grade ? to ? cardiac insufficiency, or those whose left ventricular ejection fraction (LVEF) is less than 50% as indicate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response (pCR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-Free Survival(EFS);R0 resection rate;Major Pathological Response (mPR) Rate;overall survival(OS);Safety and Tolerability; | — |
Countries
China
Contacts
Public ContactLiu Yanguo
Qilu Hospital of Shandong University
Outcome results
None listed