Stage I-III lung cancer
Conditions
Interventions
experimental group:novel oncolytic vaccine 2~4×10^7-10pfu/kg
Sponsors
Changde First People's Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Volunteer to participate in clinical research; fully understand and know the research and sign the informed consent; willing to follow and have the ability to complete all trial procedures; 2) Men and women aged 18 to 75 (including 18 and 75 years old); 3) Lung cancer stage I-III patients confirmed by histopathology; 4) Patients who have not received adjuvant treatment after surgery; 5) The Eastern Cooperative Oncology Group (ECOG) physical status score is 0 to 1; 6) The estimated survival period is not less than 1 year; 7) Organ function and hematopoietic function must meet the following requirements: Hemoglobin (HGB) >= 80g/L; White blood cell count (WBC) >= 3 x 10^9/L; Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; Platelet count (PLT) >= 80 x 10^9/L; Total bilirubin (TBIL) = 50 mL/min International normalized ratio (INR) or plasma prothrombin time (PT) <= 1.5xULN. 8) Female subjects of childbearing age must agree to take effective contraceptive measures after signing the informed consent, during the study period, and within 5 months after the last dose. 9) Can cooperate to observe adverse events and curative effects, and perform PET-CT examinations from the beginning to the end of the trial. 10) Perform CTC/PET-CT check results before the start of treatment.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following cannot be included in this study: 1) Those who have received other anti-tumor therapy (including chemotherapy, molecular targeted therapy, radiotherapy, immunotherapy, monoclonal antibody therapy) within 4 weeks before the start of the research treatment, or participated in the clinical research of other unmarketed drugs; 2) Those who are known to have been allergic to any test drug composition; 3) Pregnant or lactating women; 4) Have active autoimmune diseases and have received systemic treatment (such as corticosteroids or immunosuppressive drugs) within the past 2 years (such as but not limited to: uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis) , Hyperthyroidism, hypothyroidism [hypothyroidism without clinical symptoms or hypothyroidism caused by radiotherapy and chemotherapy can be included]; subjects suffering from vitiligo or asthma in childhood has been completely relieved, and adults without any intervention can be included) By; 5) Those who need to receive systemic corticosteroids (dose equal to or higher than 10 mg/day of prednisone) or other immunosuppressive drugs within 14 days before enrollment or during the study period; 6) Those with meningeal metastasis or symptomatic central nervous system metastasis; 7) Those who have received live vaccination within 4 weeks before the start of treatment; 8) Those who have received anti-tumor vaccines or anti-tumor treatments with systemic immune stimulation; 9) Accompanied by serious medical diseases, such as severe infections, uncontrollable diabetes, cardiovascular disease (grade III or IV heart failure as defined by the New York Heart Association classification, heart block above II degree, within the past 6 months Patients with myocardial infarction, unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc.) or lung diseases (history of interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm); 10) Hepatitis B surface antigen (HBsAg) positive and/or hepatitis B core antibody (HBcAb) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA)>10^3 copies/ml, or hepatitis C virus antibody positive; syphilis positive 11) Have a history of infection with human immunodeficiency virus, or suffer from other acquired or congenital immunodeficiency diseases; 12) Those with a history of active tuberculosis infection within 1 year before enrollment; 13) Those who suffered from other malignant tumors within 5 years before enrollment, except for any type of cancer in situ that has been cured in the past, and cured skin basal cell carcinoma or skin squamous cell carcinoma; 14) Have previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 15) Major surgery (except for baseline tumor biopsy) or severe trauma occurred within 4 weeks before the start of study treatment; 16) A history of alcohol, drug or drug abuse within the past year; 17) Those who have a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance; 18) Other severe, acute, or chronic diseases or laboratory abnormalities that may increase the risk of participating in research and research medication, or may interfere with the interpretation of research results; 19) The researcher believes that it is not suitable to participate in the research due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions related to the study drug;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| TTP;DCR;OS;Remission rate of symptoms;Quality of life; | — |
Countries
China
Contacts
Public ContactWu Jiming
Changde First People's Hospital
Outcome results
None listed