Multiple primary pulmonary nodules / lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Informed consent was provided before any study specific procedures; 2. Age between 18 and 75 years old (including 18 and 75 years old), both male and female; 3. The clinical evaluation of the main lesion was in accordance with the surgical guidelines; 4. The secondary lesion was located in the periphery of the lung, which was consistent with the treatment pointer of bronchoscopic guided ablation robot; 5. ECoG physical status was 0-1. 6. The subject has good hematopoiesis and organ function, and the laboratory test values meet the following requirements: a. The absolute neutrophil count (ANC) >= 1.5 × 10^9 / L, platelet (PLT) >= 100 × 10^9 / L, hemoglobin (HB) >= 9g / dl; (Note: no blood transfusion or use of component blood or hematopoietic stimulating factors within 14 days before the first administration); b. Serum total bilirubin (TBIL) 1.5 × ULN, the calculated creatinine clearance (Cockcroft -gault formula) >= 50 ml/min.
Exclusion criteria
Exclusion criteria: 1. Patients with previous cancer history and considering pulmonary nodules as metastasis; 2. Any systemic anticancer treatment for pulmonary nodules, including chemotherapy, radiotherapy, cytotoxic drug therapy, targeted drug therapy (including tyrosine kinase inhibitors or monoclonal antibodies), and experimental treatment before or after surgery; 3. There are unresectable or metastatic diseases, pathological reports show positive surgical margins or extranodal invasion under the microscope, or lesions left during surgery, or suspicious lesions judged by imaging after surgery; 4. Health status: a. coagulation dysfunction; b. Uncontrolled diabetes mellitus, hypertension, pulmonary infection; c. Serious or unstable mental illness (severe depression, schizophrenia, etc.); d. Serious or unstable physical diseases (heart failure, liver failure, stroke, etc.); e. Pregnant or lactating women; 5. Previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid treatment or any evidence of active interstitial lung disease; 6. A clear history of neurological or psychiatric disorders, including epilepsy or dementia; Other researchers considered that it was not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival, 3y-DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year overall survival;Safety and tolerability; | — |
Countries
China
Contacts
West China Hospital, Sichuan University