no small cell lung cancer
Conditions
Interventions
Test group:Immunotherapy combined with radioactive particle implantation therapy
control group:Radioactive particle implantation therapy
Sponsors
Yueyang Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old; 2. Pathologically confirmed NSCLC (squamous cell carcinoma or adenocarcinoma, excluding other types of NSCLC) at the first visit, and the driver gene is negative; 3. According to the UICC TNM 8th edition classification criteria, the stage is T1-3N0M0 (stage Ia-IIb) (systematic evaluation methods include CT/MRI and/or PET-CT); 4. Not suitable for surgery or stereotactic radiotherapy, decided by multidisciplinary consultation and discussion of lung cancer composed of experienced thoracic surgeons and oncologists; 5. Immunotherapy and CT-guided stereotactic ablative brachytherapy as initial treatment; 6. ECOG physical status score: 0-2 points, able to tolerate puncture; 7. Good function of major organs, no severe hypertension, diabetes and heart disease. That is, the relevant examination indicators meet the following requirements within 14 days before randomization: a) Routine blood test: 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 assessment: left ventricular ejection fraction (LVEF)>=50%; d) Blood glucose was controlled at fasting blood glucose <7.2mmol/L, non-fasting blood glucose <10mmol/L, and glycated hemoglobin <7%. 8. Signed informed consent; 9. Good compliance, family members agree to cooperate with survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Abnormal coagulation function and bleeding tendency (must be met 14 days before randomization: INR within normal values without the use of anticoagulants); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; Low-dose warfarin (1 mg orally once daily) or low-dose aspirin (daily dose not exceeding 100 mg) is allowed for prophylactic purposes under the premise that the international normalized ratio (INR) of prothrombin time is <=1.5; 2. Those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders; 3. Arterial/venous thrombotic events within 6 months before screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except for venous thrombosis caused by intravenous catheterization due to previous chemotherapy and judged to have been cured by the investigator), and pulmonary embolism. 4. Contraindications to immunotherapy; 5. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the patient's 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