no small cell lung cancer
Conditions
Interventions
Test group:Immunotherapy combined with stereotactic ablation radiotherapy
Control group:stereotactic ablation radiotherapy
Sponsors
Yueyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age>=18 years; 2. At the first visit, the pathological diagnosis was NSCLC (squamous cell carcinoma or adenocarcinoma, excluding other types of NSCLC), and the driver gene was negative; 3. According to the UICC TNM 8th edition classification criteria, the stage is T1-3N0M0 (Ia IIb stage) (systematic evaluation methods include CT/MRI and/or PET-CT); 4. Not suitable for surgical treatment, decided by a multidisciplinary consultation of experienced thoracic surgeons and oncologists for lung cancer; 5. Immunotherapy and stereotactic ablation radiotherapy are used as initial treatments; 6. ECOG physical condition score: 0-2 points; 7. The main organs function well, without serious hypertension, diabetes and heart disease. The relevant examination indicators within the first 14 days of randomization meet the following requirements: a) Blood routine examination: i. Hemoglobin>=90 g/L (no blood transfusion within 14 days); Ii. Neutrophil count>1.5 × 10 ^ 9/L; iii Platelet count >=100 × 10 ^ 9/L; b) Biochemical examination: i. Total bilirubin=60ml/min (Cockcroft Gault formula); c) Cardiac Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF)>=50%; d) Blood glucose should be controlled at fasting blood glucose<7.2 mmol/L, non fasting blood glucose<10 mmol/L, and glycated hemoglobin<7%. 8. Sign the informed consent form; 9. Good compliance, family members agree to cooperate in receiving survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Contraindications for radiotherapy; 2. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders; 3. Screening for arterial/venous thrombosis events that have occurred within the previous 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis (excluding those caused by venous catheterization during previous chemotherapy and judged to have recovered by researchers), and pulmonary embolism; 4. Contraindications for immunotherapy; 5. According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| event free survival(EFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| local control rate(LCR); | — |
Countries
China
Contacts
Public ContactXie Wangti
Yueyang Central Hospital
Outcome results
None listed