non-small cell lung cancer
Conditions
Interventions
High dose group:Albumin-bound Paclitaxel: 260mg/m2 Q3W Carboplatin AUC 5 or Cisplatin 75mg/m2 Q3W
Low dose group:Albumin-bound paclitaxel: 130mg/m2, Q3W, carboplatin AUC 3 or cisplatin 60mg/m2 Q3W
Sponsors
Changzhou Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Be able to comply with the requirements of clinical research protocol, complete all trial procedures, and sign the informed consent form; 2. The age is between 18 and 75 years old; 3. Cytological or histological diagnosis of non-small cell lung cancer; 4. According to the evaluation criteria for the efficacy of solid tumors (RECIST version 1.1), at least one imaging measurable lesion; 5. For patients with stage ?a-IIIa non-small cell lung cancer without any treatment (according to UICC/AJCC 8th edition TNM staging), the tumor diameter must be > 2cm; 6. Tissue specimen: EGFR or ALK gene mutation negative; 7. Patients who agree to undergo radical surgery; 8. Surgeons evaluate patients who can be surgically removed without contraindications to surgery; 9. ECOG score 0-1 points; 10. Expected survival time > 6 months; 11. Sufficient organ function, subjects need to meet the following laboratory indicators: 1) The absolute value of neutrophils (ANC) >= 1.5 x 10^9/L without using granulocyte colony stimulating factor in the past 14 days. 2) In the case of no blood transfusion in the past 14 days, platelets >= 100 x 109/L. 3) In the past 14 days without blood transfusion or using erythropoietin, hemoglobin>9g/dL; 4) Total bilirubin = 60 ml/min; 7) Good coagulation function, defined as the international standardized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; 8) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is out of the normal range, subjects whose total T3 (or FT3) and FT4 are within the normal range can also be included in the group; myocardial enzyme spectrum is within the normal range (if the investigator judges it as a pure experiment that has no clinical significance) Room abnormalities are also allowed to join the group). 12. For female subjects of childbearing age, a urine or serum pregnancy test and the result should be negative within 3 days before receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-bearing age are defined as at least 1 year after menopause, or have undergone surgical sterilization or hysterectomy. 13. If there is a risk of pregnancy, all subjects (whether male or female) need to adopt a low annual failure rate during the entire treatment period until 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration) Less than 1% of contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of other malignant diseases other than non-small cell lung cancer within 5 years before the first administration (excluding radically cured skin basal cell carcinoma, skin squamous epithelial carcinoma, and/or radically resected carcinoma in situ). 2. Currently participating in interventional clinical research treatment, or received other research drugs or used research devices within 4 weeks before the first administration. 3. Have received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or for another stimulating or synergistic inhibition of T cell receptors (for example, CTLA-4, OX-40, CD137) drug. 4. Received Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) systemic systemic treatment within 2 weeks before the first administration. 5. An active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, glucocorticoids, or immunosuppressive agents) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments. 6. The study is receiving systemic glucocorticoid therapy (not including nasal spray, inhaled or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study. Note: physiological doses are allowed Glucocorticoid (<=10 mg/day prednisone or equivalent). 7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation 8. Those who are known to be allergic to the active ingredients or excipients of Sintilimab. 9. Before starting treatment, have not fully recovered from toxicity and/or complications caused by any intervention (ie, <= Grade 1 or reached baseline, excluding fatigue or hair loss). 10. Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive). 11. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number is greater than the upper limit of the normal value of the laboratory department of the research center); Note: Hepatitis B subjects who meet the following criteria can also be included: 1) Before the first administration, the HBV viral load is less than 1000 copies/ml (200 IU/ml), and the subject should receive anti-HBV treatment during the entire study chemotherapy drug treatment to avoid viral reactivation. 2) For anti-HBc(+), HBsAg( -) Subjects with anti-HBs (-) and HBV viral load (-) do not need to receive preventive anti-HBV treatment, but need to closely monitor virus reactivation. 12. Active HCV infected subjects (HCV antibody positive and HCV-RNA level is higher than the lower limit of detection). 13. Live vaccine has been vaccinated within 30 days before the first dose (cycle 1, day 1); Note: It is allowed to receive inactivated virus vaccine for seasonal influenza injection within 30 days before the first dose; however, intranasal medication is not allowed Live attenuated influenza vaccine. 14. Pregnant or lactating women. 15. There are any serious or uncontrollable systemic diseases, such as: 1) There are major abnormalities in rhythm, conduction or morphology in the resting ECG that have serious symptoms that are difficult to contr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood RT;Urine RT;liver function;renal function;biochemistry;Myocardial zymogram;Blood lipids;Coagulation RT;Thyroid Hormone;HBV-DNA;HCV-RNA;ECG;Gene Sequencing; | — |
Countries
China
Contacts
Public ContactJiang Hua
Changzhou Second People's Hospital
Outcome results
None listed