Lung Cancer
Conditions
Interventions
Immunotherapy group after microwave ablation:Microwave ablation + PD-1 monoclonal antibody treatment
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18-79 years; 2) Multiple pulmonary nodules diagnosed by CT, the number of target lesions is >= 2 and = 8 mm or the largest diameter of a solid component is >= 5mm, and a single nodule is the largest Diameter = 12 months; 7) Sufficient hematology function, defined as absolute neutrophil count >= 1.5 x 10^9/L, platelet count >= 80 x 10^9/L, hemoglobin >= 90g/L (no history of blood transfusion within 7 days, no G-CSF and others Correction of hematopoietic stimulating factors); 8) Sufficient liver function, defined as all patients with total bilirubin level = 50ml/min (Cockcroft-Gault formula); 10) The coagulation function is adequate, defined as the international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; if the subject is receiving anticoagulation therapy, as long as the INR/PT is within the proposed range of anticoagulation drugs Can; 11) For female subjects of childbearing age, the urine or serum pregnancy test should be negative within 3 days before receiving the first study drug administration. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required; 12) If there is a risk of conception, male and female patients need to use high-efficiency contraception (that is, a method with a failure rate of less than 1% per year) and continue until at least 180 days after stopping the trial treatment; 13) Subjects voluntarily join the study and sign written informed consent before any trial-related procedures are implemented. They have good compliance and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1) Genetic testing is positive for at least one mutation of EGFR, ALK, ROS1 fusion, BRAF V600E mutation, and NTRK fusion; 2) Pulmonary nodules with the largest diameter > 30mm in preoperative imaging examination; 3) Preoperative imaging examination or mediastinal lymph node puncture indicates patients with positive preoperative lymph nodes; 4) Patients with distant metastasis or chest or ascites found in preoperative examination; 5) Currently participating in interventional clinical research treatment, or receiving treatment with other research drugs or research devices within 3 months before the first intervention; 6) Any systemic anti-tumor treatment before tumor ablation, including interventional chemoembolization, radiotherapy, chemotherapy, targeted therapy, or Chinese patent medicine with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) ), or received major surgery within 3 weeks before the first intervention; 7) Have received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (for example, CTLA4, OX-40, CD137); 8) There are multiple factors that affect surgery or ablation (such as coagulation dysfunction, immune system disease, etc.); 9) Abnormal coagulation function (PT > 16 s, APTT > 43 s, TT > 21 s, Fbg = CTCAE grade 2 occurred within 4 weeks before the first intervention; other parts of hemorrhage >= CTCAE grade 3 occurred within 4 weeks before treatment; 11) Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive), known syphilis infection (syphilis antibody positive), active tuberculosis, active hepatitis without treatment; 12) People with severe impairment of heart, liver, and kidney functions (heart function grades 3 to 4, ALT and/or AST are more than 3 times the upper limit of normal, and Cr exceeds the upper limit of normal); 13) Known mental illness or drug abuse that may affect compliance with test requirements; 14) Patients with other malignant tumors or hematological diseases; 15) Pregnant, planned pregnancy and breast-feeding women (when urine HCG>2500IU/L, the diagnosis is early pregnancy pregnant); 16) The investigator believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival at the 2ed, 3rd and 5th year;Incidence of clinically significant toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival at the 3rd and 5th year;Postoperative quality of life score;Incidence of complications;Non-target lesion progression-free rate; | — |
Countries
China
Contacts
Public ContactChen Chang
Shanghai Pulmonary Hospital
Outcome results
None listed