Non-small cell lung cancer
Conditions
Interventions
mRNA drug treatment group:Surgical treatment + carrilizumab treatment +PCV injection + chemotherapy
Sponsors
Third People's Hospital of Yancheng
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Volunteer to participate in this trial and sign the informed consent form. 2) 18-75 years old, male or female. 3) Pathology and imaging confirm that the subject is a patient with resectable primary non-small cell lung cancer. The tissue of the subject with complete macroscopic resection (R0) after surgical resection is used for mRNA drug development. 4) ECOG score is 0 or 1. 5) Estimated survival period >= 12 weeks. 6) The subject has not received chemotherapy, radiotherapy or immunotherapy for NSCLC before. 7) The main organ function is sound: serum creatinine clearance meets the relevant age/gender standards, and alanine aminotransferase and aspartate aminotransferase are less than 3 times the upper limit of the normal range.
Exclusion criteria
Exclusion criteria: 1) Previous neoadjuvant therapy or radiotherapy for NSCLC; previous treatment with aPD-1 antibody or any other immunotherapy; marginally resectable, locally unresectable or metastatic NSCLC, etc. 2) Subjects with known allergic reactions, hypersensitivity reactions, intolerances or contraindications to mRNA drugs or any drug components that may be used in the study (including carrelizumab, cisplatin and albumin paclitaxel), or who have had severe allergic reactions in the past. 3) Subjects with active bacterial, viral or fungal infections requiring systemic treatment, defined as subjects with persistent signs/symptoms related to infection that have yet to improve despite appropriate antibiotics, antiviral therapy and/or other treatments. 4) Subjects with hepatitis B or C infection, or a history of human immunodeficiency virus (HIV) infection, or receiving immunosuppression or bone marrow suppression; drugs that the investigator believes will increase the risk of severe neutropenia complications. 5) Serious medical risk factors involving any major organ system, or severe mental illness that may jeopardize the safety of the subject or the integrity of the study data. 6) Female subjects who are pregnant, breastfeeding, or planning to become pregnant within 90 days after the last dose of study treatment. 7) Subjects with a history of other primary cancers will be treated concurrently with the study drug in this study. 8) New York Heart Association (NYHA) III-IV heart failure, uncontrolled hypertension, clinically significant arrhythmias, or electrocardiogram (ECG) abnormalities, cerebrovascular accidents, transient ischemic attacks, or epileptic seizures. 9) History of autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular and antiphospholipid syndrome, Wegener syndrome-related thrombotic granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. 10) Previous allogeneic bone marrow transplantation or solid organ transplantation. 11) Any condition that the investigator believes may increase the risk of the subject or interfere with the results of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment Emergent Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);Disease-free-survival; | — |
Countries
China
Contacts
Public ContactShi Woda
Third People's Hospital of Yancheng
Outcome results
None listed