non-small cell lung cancer
Conditions
Interventions
treatment group:reRNA-EGF vaccine/PD-1 toripalimab injection
Sponsors
The Second Affiliated Hospital of Bengbu Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old = 10mm (if it is a malignant lymph node, the short diameter is required to be >= 15 mm); 4. The Eastern Cooperative Oncology Group Physical Status Score (ECOG PS) is 0-2 points; 5. Expected survival period >= 6 months; 6. Serum EGF concentration >= 870pg/ml during the screening period; 7. Have adequate organ and bone marrow function, as defined below: 1) Blood routine: absolute neutrophil count (ANC) >= 1.5×10^9/L; platelet count (PLT) >= 75×10^9/L; hemoglobin content (HGB) >= 80 g/L. No use of granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), red blood cell transfusion and platelet transfusion within 14 days before the examination; 2) Liver function: Study participants without liver metastasis require serum total bilirubin (TBIL) <= 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5×ULN. Requirements for study participants with liver metastases: TBIL <= 1.5×ULN; ALT and AST <= 5×ULN; 3) Renal function: serum creatinine (Scr) <= 1.5×ULN; 4) Sufficient coagulation function, defined as international normalized ratio (INR) <= 1.5 or prothrombin time (PT) <= 1.5 times ULN; if the research participant is receiving anticoagulant therapy, as long as PT is within the range prescribed by the anticoagulant drug Can. 8. Qualified patients (male and female) with reproductive potential must agree to use reliable contraceptive methods (hormone or barrier method or abstinence) within 6 months after EGF vaccine injection administration; female patients of childbearing age within 7 days before enrollment The blood pregnancy test must be negative; 9. Fully understand the purpose, nature, method and possible adverse reactions of the trial, be a voluntary participant, and sign an informed consent form (ICF) before any procedure begins.
Exclusion criteria
Exclusion criteria: 1. Have a history of severe allergy to biological products; 2. Those who are pregnant or breastfeeding; 3. Those who have undergone major organ surgery (excluding biopsy puncture) within 4 weeks before the first use of the study drug, or plan to undergo major surgery during the study period; 4. Received chemotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor drug treatments (including experimental treatments) within 2 weeks before the first administration; 5. Received live virus vaccine within 4 weeks before the first administration; 6. Patients who have received systemic corticosteroids (prednisone > 10mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days before the first administration; except for the following cases: use topical, ocular, Intra-articular and intranasal corticosteroids; short-term prophylaxis with corticosteroids; 7. Patients with known or screening findings of active CNS metastases and/or cancerous meningitis. However, the following research participants are allowed to enroll: (1) Patients with asymptomatic brain metastases (that is, no progressive central nervous system symptoms caused by brain metastases and do not need to use corticosteroids) can participate. (2) Research participants who have been treated and have stable brain metastases for at least 2 months, without evidence of new or enlarged brain metastases; 8. The adverse reactions of the previous anti-tumor therapy have not recovered to NCI CTCAE v5.0 grade evaluation = 160 mmHg or diastolic blood pressure >= 100mmHg); b. Cardiac function >= grade 2 congestive heart failure (New York Heart Association (NYHA) classification); c. Arrhythmias requiring clinical intervention (including QTc >= 450ms (male), QTc >= 470ms (female)); d. Serious arterial and venous thromboembolic events, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism (excluding Intermuscular venous thrombosis, myocarditis and other medical history that can be included in the evaluation; 10. Accompanied by uncontrolled third-space effusion that requires repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc. (patients who do not need to drain the effusion or have no significant increase in effusion after 3 days of stopping drainage can be enrolled); 11. HIV, HCV, syphilis, CMV, EBV infected patients; patients with active replication of hepatitis B virus (DNA > 500 cps/mL); 12. Patients with interstitial lung disease (requiring steroid use), idiopathic pulmonary fibrosis, pneumonia (including drug-induced pneumonia) or organizing pneumonia (eg, bronchiolitis obliterans, cryptogenic organizing pneumonia) medical history; Note: Asymptomatic pneumonia patients who do not require steroid therapy for lung inflammation can be enrolled in the study. 13. Suffering from active autoimmune disease or inflammatory disease (including inflammatory bowel disease [such as ulcerative colitis or Crohn's disease], diverticulitis [except diverticular disease], celiac disease, systemic lupus erythema
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum EGF concentration before and after treatment and anti-EGF antibody titer after treatment;Antibody response to vaccination in study participants (GAR) with EGF antibody titers = 1:4000;overall response rate;disease control rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactLi Ziguang
The Second Affiliated Hospital of Bengbu Medical College
Outcome results
None listed