Lung cancer
Conditions
Interventions
CT-guided percutaneous cryoablation:CT-guided percutaneous cryoablation
Bronchoscopic cryoablation group:Bronchoscopic cryoablation
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. age >=18 years old; 2. ECOG score was 0-1 at randomization; 3. Histologically or cytologically confirmed advanced/metastatic or unresectable NSCLC with negative driver gene testing (EGFR/ALK/ROS1) regardless of PD-L1 expression status; 4. Imaging examination showed that there were no more than 5 residual lesions in the patient's lung, and all lesions could be treated with cryoablation; 5. After receiving 4 cycles of standardized chemotherapy combined with immunotherapy, the target lesion response was evaluated as partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Exclusion criteria
Exclusion criteria: 1. Diffuse lesions in both lungs could not be improved by ablation. Patients with leptomeningeal metastases or uncontrolled brain metastases; Uncontrolled metastases to other organs (bone, liver, adrenal gland, etc.) 2. patients with contraindications to bronchoscopy or lung puncture, or who cannot tolerate or are difficult to cooperate with bronchoscopy or CT-guided lung puncture; 3. severe bleeding tendency and uncorrectable coagulation dysfunction (prothrombin time >18 s, prothrombin activity <40%); Platelet count <70×10^9/L, or discontinuation of anticoagulant therapy and/or antiplatelet drugs for less than 1 week before ablation (except preoperative prophylactic use of low molecular weight heparin); 4. expected survival time less than 3 months; 5. Poor general condition (multiple metastases, severe infection, high fever), perifocal infection and radiation inflammation, obvious cachexia, severe organ dysfunction, severe anemia and nutritional and metabolic disorders that could not be improved in a short time; 6. Patients with a history of active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) infection (known HIV1/2 antibody positive), or other active infections that may affect patients' treatment according to the investigator's judgment; 7. pregnant, lactating, or male or female patients who plan to give birth or become pregnant during the trial; 8.4 after standard chemotherapy combined with immunotherapy, grade 2 or above immune checkpoint inhibitor associated pneumonia (CIP) occurred.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival;Ablation implementation effectiveness rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Duration of Response;Safety parameter; | — |
Countries
China
Contacts
Public ContactJianya Zhou
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed