Non-small cell lung cancer
Conditions
Interventions
Experimental group:New adjuvant regimen: Chemotherapy regimen: If the pathological type is squamous cell carcinoma, albumin paclitaxel (200mg/m2) plus cisplatin (75mg/m2) is used. If the pathological
The purpose of the immunotherapy monotherapy regimen is to screen patients who are sensitive to immunotherapy. The surgical plan is (within 4 weeks after the end of immunotherapy): thoracoscopic media
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Able to provide written informed consent, and can understand and agree to comply with the requirements of this study as well as the evaluation schedule. 2. Have been at least 18 years old and less than 70 years old on the date of signing the informed consent form (confirmed by histology after EBUS biopsy for N3 IIIB, IIIC stage non-small cell lung cancer Staging should be based on the 8th edition of the American Joint Committee on Cancer/International Union Against Cancer (IUC) NSCLC staging system. Patients with clinical stage T1-4N3M0 were enrolled: T1: the maximum diameter of the tumor was 3cm, 5cm, 7cm; Regardless of size, it affects any of the following organs, including: mediastinum, heart, large vessels, carina, recurrent laryngeal nerve, main trachea, esophagus, vertebral body, diaphragm; Solitary cancerous nodules in different lobes of the same side. N3: metastasis to contralateral mediastinal lymph nodes. 3. Patients will be tested for pulmonary function within 6 months prior to planned resection, and can be retested at screening if clinically indicated, with test indicators including lung volume, respiratory spirometry and diffusion capacity. If pulmonary function tests are abnormal, further evaluation can be done with quantitative ventilation/perfusion scans or cardiopulmonary exercise testing. Postoperatively, a one-second forced respiratory volume predicted percent forced expiratory volume (FEV1) and diffusion capacity test must be performed with a predicted percentage of >=40%, and/or maximum oxygen consumption (VO2max) of > = 10 points ratio (FEV1) and a diffusion capacity test, with a predicted percentage of >=40%, and/or a maximum oxygen consumption (VO2max) of >= 10 mL/kg/min. 4. Cardiac function is good, and it is confirmed that surgical resection for the purpose of curative treatment is met. a. If clinically indicated, a cardiologist should evaluate the patient for an underlying disease such as ischemic, valvular or other major cardiac disease before surgery. 5. Measurable disease as assessed by the investigator according to RECIST version 1.1. 6. ECOG performance status of 0 or 1. 7. During the screening process or = 1.5x10^9/L, platelet > = 75×10^9/L, hemoglobin > = 90 g/L when the following items are tested during the screening period; b. Glomerular filtration rate (GFR) estimated by the Cooperative Equation of Epidemiology of Chronic Kidney Disease >=45mL/min/1.73 m2, patients who planned to receive carboplatin: GFR >=45 mL/min. c. Serum total bilirubin < = 1.5 × upper limit of normal (ULN) (total bilirubin must be <3×ULN in patients with Gilbe
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Previous treatment for current lung cancer, including targeted, immunotherapy, chemotherapy, or radiotherapy. 2. Active autoimmune disease or history of autoimmune disease that may recur. Note: Patients with the following conditions do not need to be excluded and can proceed for further screening: Well-controlled type I diabetes Hypothyroidism (as long as it is treated with hormone replacement therapy alone) Well-controlled celiac disease Skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, alopecia) Any other disease that is not expected to recur in the absence of an external trigger 3. 10 mg/day) or other immunosuppressive drugs within 10 mg/day) Topical, ocular, intra-articular, intranasal, or inhaled corticosteroids with very low systemic absorption Short-term ( grade 1 (regardless of whether standard medical management is used) or >= Grade 3 hypoalbuminemia. 6. Have a history of interstitial lung disease, non-infectious pneumonia, or poorly controlled diseases, including pulmonary fibrosis, acute lung disease, etc. 7. Severe chronic or active infection requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. Severe infection within 4 weeks prior to enrollment, including but not limited to hospitalization for infection, bacteremia or complications of severe pneumonia. Received oral or intravenous antibiotic therapy 2 weeks prior to enrollment. 8. Known history of HIV virus infection. 9. Patients with untreated chronic hepatitis B or HBV carriers with hepatitis B virus (HBV) DNA >=500IU/mL, or patients with active hepatitis C virus (HCV) should be excluded. Note: Patients with inactive hepatitis B surface antigen (HBsAg), treated and stable hepatitis B carriers (HBV DNA <500 IU/mL), and cured hepatitis C patients can be enrolled. 10. If any major surgical procedure requiring general anesthesia has been performed within <=28 days prior to enrollment in the group. 11. Previous allogeneic stem cell transplantation or organ transplantation. 12. Any of the following cardiovascular risk factors: Cardiogenic chest pain within 28 days prior to enrollment (inclusive), defined as moderate pain with instrumental limitation of activities of daily living. Symptomatic pulmonary embolism within 28 days (inclusive) prior to enrollment. Any history of acute myocardial infarction within 6 months (inclusive) prior to enrollment grouping. Any history of heart failure consistent with New York Heart Association classification class III or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative complications within 30 days;Mortality within 30 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative pathological pCR rate;Postoperative pathological MPR rate; | — |
Countries
China
Contacts
Public ContactDaxing Zhu
West China Hospital, Sichuan University
Outcome results
None listed