Lung Cancer
Conditions
Interventions
Group 2:Ablation plus immunotherapy
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with advanced non-small cell lung cancer (IIIB and IV stages of different lobes of the same lung) confirmed by cytology or pathology; 2. Patients who received first-line immunosuppressant (PD-1 / PD-L1 inhibitor) 4-6 months later were evaluated as PR or SD, and PET / CT showed that there were less than 3 residual active lesions in the lung (all lesions were less than 5 cm); 3. The remaining lesions could be completely ablated; 4. Patients in the Eastern Cooperative Oncology Group with a performance status (ECoG) score of 0-1; 5. Patients with good functional status are as follows: (1) Left ventricular ejection fraction > 50% or normal range; (2) neutrophil count > 1500 / mm3; (3) Platelet count > 75000 / mm3; (4) Creatinine clearance rate > 45ml / min; (5) Total bilirubin < 1.5 times the upper limit of normal value (total bilirubin < 4 times the upper limit of normal value in patients with Gilbert's syndrome); (6) Ast or ALT < 3 times of the upper limit of normal value (less than 5 times of the upper limit of normal value in patients with liver metastasis); 6. Patients over 18 years old; 7. Informed consent is in line with ICH-GCP principles.
Exclusion criteria
Exclusion criteria: 1. Patients with symptomatic brain metastasis; 2. Patients with previous or existing cardiovascular abnormalities, such as refractory hypertension, congestive heart failure (NYHA III), unstable angina or refractory arrhythmia, who had myocardial infarction in the first six months at random; 3. Patients with other serious persistent diseases or organ system dysfunction that the researchers believe may impair patient safety or interfere with the safety assessment of the investigational drug; 4. A woman of childbearing age of planned pregnancy or a man of childbearing age of planned parenthood; 5. Pregnant or lactating women; 6. Patients who could not follow the protocol provided by the investigator; 7. Patients with other contraindications for ablation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Time to local progression;Ablation efficacy;Objective response rate; | — |
Countries
China
Contacts
Public ContactShengxiang Ren
Shanghai Pulmonary Hospital
Outcome results
None listed