Efficacy and Safety of Cryoablation with Robotic Bronchoscopy System in Patients with Lung Cancer

Launched by GUANGZHOU MEDICAL UNIVERSITY · Feb 12, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option for patients with lung cancer who cannot undergo traditional surgery. The treatment being studied is called robotic bronchoscopy system (RBS)-assisted cryoablation, which uses extreme cold to destroy cancerous tumors in the lungs. The main goals of the trial are to see if this method can successfully remove tumors and to determine if it is safe for patients. To participate, individuals must be at least 18 years old, have a specific type of lung cancer that is 3 cm or smaller, and either cannot or do not want to receive other treatments like chemotherapy or surgery.

Participants in the trial will undergo several evaluations before the procedure to ensure they are suitable candidates. They will receive the cryoablation treatment while under general anesthesia and will be monitored for safety during and after the procedure. Follow-up visits will occur at 1, 3, 6, and 12 months to check on their health and how well the treatment worked. It's important to note that there are specific criteria that might exclude some patients from participating, such as having severe lung issues or active infections. Overall, this trial aims to provide insights into a promising new approach for treating lung cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • (1) Age ≥ 18 years old, regardless of gender. (2) Diagnosed with peripheral lung cancer, with the maximum diameter of the tumor ≤ 3 cm and the number of tumors ≤ 3. (3) The lesion to be ablated is evaluated as suitable for bronchoscopy-guided cryoablation treatment. (4) The subject refuses or is deemed unsuitable for radiotherapy/chemotherapy, or shows no response to previous radiotherapy/chemotherapy, or experiences disease progression after radiotherapy/chemotherapy. (5) Assessed as ineligible for surgery or refuses surgery and radiotherapy, consents to receive initial ablation treatment, and signs the informed consent form.
• Exclusion Criteria:
• • (1) Diffuse lesions in both lungs where ablation treatment is unlikely to improve the condition. (2) Presence of hilar lymph node metastasis or extrapulmonary metastasis as indicated by examinations within 1 month before the operation (except for extrapulmonary metastasis that has been controlled by local treatment). (3) Presence of contraindications for bronchoscopy, or inability to tolerate or cooperate with bronchoscopy. (4) Severe bleeding tendency, uncorrectable coagulation dysfunction (prothrombin time \> 18 s, prothrombin activity \< 40%). (5) Platelet count \< 70×109/L, or anticoagulant and/or antiplatelet drugs have not been discontinued for more than 1 week before ablation (except for prophylactic use of low-molecular-weight heparin before the operation). (6) Severe impairment of lung function, with maximum ventilation \< 40%. (7) Concurrent with other tumors and extensive metastasis, with an expected survival period of less than 3 months. (8) Poor general condition (multiple metastases throughout the body, severe infection, high fever), infectious and radiation-induced inflammation around the lesion, obvious cachexia, severe insufficiency of vital organs, severe anemia and nutritional metabolic disorders that cannot be improved in the short term. (9) Eastern Cooperative Oncology Group (ECOG) performance status score \> 2. (10) The lesion to be ablated has received radiotherapy within the past 6 months. (11) Presence of active hepatitis B, active hepatitis C, history of human immunodeficiency virus (HIV) infection (known positive for HIV 1/2 antibodies), or other active infections that may affect the patient's treatment as judged by the investigator. (12) Accompanied by epilepsy, history of mental illness or cognitive impairment. (13) Pregnant or lactating women, and male or female patients planning to conceive or become pregnant during the trial. (14) Participation in any other clinical trial within 3 months before signing the informed consent form (except for non-interventional studies). (15) Other circumstances considered inappropriate for participation in this clinical trial by the investigator.