non-small cell lung cancer
Conditions
Interventions
experimental group:During neoadjuvant treatment of operable NSCLC, standard neoadjuvant treatment plan was combined with Nocardia Rubra Cell Wall Skeleton for Injection (N-CWS) 200 µg subcutaneously w
Sponsors
The East Division of the First Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, regardless of gender; 2. ECOG physical status score is 0 ~ 1; 3. According to the IASLC seventh edition staging, pathologically confirmed IB (> 3cm), II, IIIA (excluding N2) (AJCC lung cancer TNM staging eighth edition) resectable NSCLC patients (squamous cell carcinoma, adenocarcinoma And large cell lung cancer, etc.); 4. According to RECIST VERSION 1.1, there are measurable lesions; 5. Expected survival time >= 3 months; 6. Cardiopulmonary function is evaluated to tolerate surgery, FEV1 >= 1.5L and DLCO is not less than 80% of the predicted value. 7. The functional levels of major organs meet the following standards: (1) The standard for routine blood tests must meet: hemoglobin >=10 g / dL, platelets >= 100,000 / µL, and absolute neutrophil count >= 1500 / µL; (2) Biochemical examination should meet the following standards: serum creatinine = 60 ml / min, serum bilirubin <= 1.5 times UNL, AST and ALT <= 2.5 times UNL, alkaline phosphatase <= 5 times UNL; 8. Women of childbearing age must have taken reliable contraceptive measures, or performed a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they are willing to use appropriate Method of contraception; 9. Participants voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Known allergy to the study drug or any of its accessories; 2. Patients with severe heart, liver, kidney and endocrine system diseases, and the expected survival time of the above diseases is less than 2 years; 3. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA >= 500 IU / ml), hepatitis C (hepatitis C antibody positive, and HCV- RNA is higher than the detection limit of the analytical method) or co-infected with hepatitis B and C; 4. Patients undergoing anticoagulant therapy before or before surgery; 5. Known tendency of inherited or acquired bleeding and thrombosis, such as: hemophilia, coagulation skills disorder, thrombocytopenia, hypersplenism, etc.; 6. Known history of psychotropic substance abuse or drug use; 7. Patients who have previously used chemotherapy or any other cancer treatment; 8. Patients with active malignant tumors in the past 3 years, except for those that have been obviously cured, can cure cancer, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of prostate, cervix or breast. 9. There are other serious physical or mental diseases or abnormal laboratory tests, which may increase the risk of participating in the study, or interfere with the results of the study, and patients who the investigator believes are not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathologic response rate (MPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;R0 resection rate;DCR;Adverse event rate of N-CWS; | — |
Countries
China
Contacts
Public ContactChen Zhenguang
Outcome results
None listed