Lung cancer
Conditions
Interventions
Experimental group:Robotic bronchoscopy navigation and cryoablation
Sponsors
The Fourth Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 2. Diagnosed with primary peripheral non-small cell lung cancer, with preoperative staging test suggesting clinical stage III-IV; genetic test suggesting EGFR mutation, having been treated with first-line TKI therapy, assessed to be SD or PR for at least 12 months, and with the maximum diameter of the tumour <=3cm, and the number of tumours <=3; 3. The lesion to be ablated is assessed to be feasible for cryo-ablation therapy with robotic bronchoscopy ; 4.Agree to receive cryo-ablation therapy; sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Diffuse lesions in both lungs that cannot be improved by ablative therapy; tumours with a maximum diameter of >=3 cm and a number of >=3; 2. Hilar lymph node metastases or extrapulmonary metastases (except for extrapulmonary metastases that are controlled by local treatment) as shown by the examination within 1 month prior to the operation; 3. Contraindications to bronchoscopy, or those who are unable to tolerate or have difficulty in cooperating with the bronchoscopy examination; 4. Severe bleeding tendency, uncorrectable coagulation dysfunction (prothrombin time >18 s, prothrombin activity 2; 10. Radiotherapy to the proposed ablation lesion within the past 6 months; 11. Active hepatitis B, active hepatitis C, a history of human immunodeficiency virus (HIV) infection (known to be HIV1/2 positive), or other active infections that, in the judgement of the investigator, may interfere with the patient's ability to undergo treatment; Other active infections; 12. People with epilepsy, history of psychosis, or cognitive impairment; 13. Pregnant or breastfeeding women, and male or female patients who plan to give birth to a child or become pregnant during the trial; 14. Participation in any other clinical trial (other than non-interventional studies) within 3 months prior to the date of signing the informed consent form; 15. Patients with electromagnetic active implantable devices in their body; 16. Other conditions that are deemed inappropriate for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ablation success rate;Robot Navigation Success Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of therapeutic effect on local lesions;Instrument operability; | — |
Countries
China
Contacts
Public ContactJunhong Jiang
The Fourth Affiliated Hospital of Soochow University
Outcome results
None listed