lung tumor
Conditions
Interventions
Ablation group:Percutaneous/bronchoscopy thermal ablation
Surgery group:Surgical removal of lung nodules
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 80 years old; 2. Pulmonary nodules diagnosed by CT, the lesions are only in the single lung lobe and the total number should not exceed 3, the lesion size is 8--20mm and no anti-tumor treatment has been received; 3. Diagnosis of lung cancer by pathology; 4. ECOG PS score: 0-1 points; 5. Expected survival time >= 12 months; 6. The function of main organs is normal, that is, it meets the following standards: (1) The blood test standard must meet: a. HB >= 120g / L (without blood transfusion within 14 days); b. ANC >= 2.0 x 10^9 / L; c. PLT >= 100 x 10^9 / L (2) The biochemical inspection must meet the following standards: a. BIL 50ml / min (Cockcroft-Gault formula); 7. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with metastatic lesions or nodules other than lung nodules and highly suspected or diagnosed as tumors; 2. Patients with multiple lung lobe multiple lesions or single lung lobe lesions exceeding 3; 3. Patients diagnosed with non-lung cancer by pathology; 4. Pregnant or lactating women; 5. People with high blood pressure who cannot be reduced to the normal range by antihypertensive drugs (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg), with myocardial ischemia or myocardial infarction, arrhythmia (including QT Interval >= 440 ms) and class I cardiac insufficiency; 6. There are many factors that affect surgery or ablation (such as moderate to severe lung dysfunction, coagulopathy, immune system diseases, etc.); 7. Abnormal blood coagulation function (PT > 16 s, APTT> 43 s, TT> 21 s, Fbg = CTCAE grade 2 occurred within 4 weeks before the visit; bleeding of other sites of >= CTCAE grade 3 occurred within 4 weeks before the visit; 9. Long-term unhealed wounds or fractures; 10. Arterial / venous thrombotic events that occurred within 6 months before the visit, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism; 11. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or the like; on the premise that the international normalized ratio of prothrombin time (INR) <= 1.5, it is allowed to use small doses of Hua for prophylactic purposes Farin (1mg oral, once daily) or low-dose aspirin (daily dosage between 80mg and 100mg); 12. Those who have a history of psychotropic substance abuse and are unable to quit or have mental disorders; 13. Participated in other clinical trials within 3 months; 14. Have used any anti-tumor medicine (including Chinese medicine), equipment and surgical treatment; 15. Previous history of malignant tumor or concurrent with other malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress-free survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission rate;overall survival time; | — |
Countries
China
Contacts
Public ContactHao Wang
Shanghai Pulmonary Hospital
Outcome results
None listed