Non-small cell lung cancer
Conditions
Interventions
Ametinib assisted group:Thermal ablation will be followed by initiation of Ametinib (110 mg once daily, oral) within one week, with a total treatment duration of one year.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign the written informed consent before implementing any test related process; 2. Age >= 18 and = 75 years, pulmonary hypertension LVEF 45 mmHg during breathing or exercise; 6. Provide sufficient quality control qualified tumor tissue or cell wax to detect and confirm the EGFR mutation sensitive to ametinib; 7. He has not received any systematic anti-tumor therapy in the past; 8. ECOG score is 0~2 points; 9. The expected survival time was>6 months; 10. Sufficient organ function, study participants need to meet the following laboratory indicators: The absolute value of neutrophils (ANC) >= 1.5 × 10^9/L without granulocyte colony stimulating factor in the past 14 days; Platelets >= 50 × 10^9/L without blood transfusion in recent 14 days; Hemoglobin>9g/dL without blood transfusion or use of erythropoietin in recent 14 days; Total bilirubin = 60 ml/min; Good coagulation function was defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is beyond the normal range, the study participants can also be enrolled if the total T3 (or FT3) and FT4 are within the normal range; The myocardial enzyme spectrum is within the normal range (for example, simple laboratory abnormalities that are not clinically significant according to the comprehensive judgment of the researcher are also allowed to be included in the group); 11. For female study participants of childbearing age, they should receive urine or serum pregnancy test within 3 days before receiving the first study drug administration (the first day of the first cycle) and the result is negative. If the result of urine pregnancy test cannot be confirmed as negative, blood pregnancy test is required. Women of non reproductive age were defined as having been postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy; 12. If there is a risk of pregnancy, all study participants (ma
Exclusion criteria
Exclusion criteria: 1. Participants who meet the following criteria cannot be enrolled in this study: (1) Pathology was small cell lung cancer (SCLC), including lung cancer with SCLC and NSCLC mixed; 2. Super central type, or close to the pleura<1cm; 3. Multiple primary tumors; 4. Before the ablation probe puncture on the skin, the anesthesia was intolerant, and the study participants were judged not suitable to participate in the study; 5. Before the ablation probe puncture on the skin, the study participants were judged not suitable to participate in the study according to other conditions; 6. Active hemoptysis (at least 1/2 teaspoon of blood at a time) occurred within 2 weeks before the administration of the first study drug; 7. Major surgical treatment was performed within 3 weeks after the first study drug administration (except for surgery for biopsy); 8. Infectious and radioactive inflammation around the lesion and skin infection at the puncture site were not well controlled; 9. Other malignant diseases other than NSCLC diagnosed within 2 years before the first administration (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and/or cancer in situ after radical resection); 10. Currently participating in the intervention clinical research treatment, or having received other research drugs or used research instruments within 4 weeks before the first administration; 11. Within 2 weeks before the first administration, he received systemic treatment with Chinese patent medicine with anti lung cancer indications or drugs with immunomodulatory effect (including thymosin, interferon, interleukin, except for local use to control pleural effusion); 12. Active autoimmune diseases requiring systemic treatment (such as the use of disease relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Replacement therapy (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered as systemic therapy; 13. The study was receiving systemic glucocorticoid therapy (excluding local glucocorticoids via nasal spray, inhalation or other routes) or any other form of immunosuppressive therapy within 7 days before the first administration. Note: it is allowed to use physiological doses of glucocorticoids (<= 10 mg/day of prednisone or equivalent drugs); 14. There is clinically uncontrollable pleural effusion/peritoneal effusion (study participants who do not need to drain effusion or who have no significant increase in effusion after stopping drainage for 3 days can be enrolled); 15. Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation are known; 16. Known to be allergic to the study drug ametinib; 17. Patients with multiple factors affecting oral medication (such as inability to swallow, after gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.); 18. Study participants with bleeding tendency (such as active peptic ulcer) or treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; On the premise that the international normalized ratio of prothrombin time (INR) <= 1.5, it is allowed to use low-dose warfarin (<= 1mg/d), low-dose heparin (<= 12000 U/d) or low-dose aspirin (<= 100mg/d) for preventive purposes; Anticoagulant therapy and/or antiplatelet drugs (except for dabigatran, rivar
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival (EFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Local control rate;Overall survival; | — |
Countries
China
Contacts
Public ContactLiao Hu
West China Hospital of Sichuan University
Outcome results
None listed