Clinical trial NCT04619472: Safety and Effectiveness of Radiofrequency Ablation System in the Treatment of Peripheral Lung Tumors
Official title: A Multicenter, Single Group Target Value Clinical Study to Evaluate Safety and Effectiveness of Radiofrequency Ablation System in the Treatment of Peripheral Lung Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms
Pulmonary Metastasis
Keywords: Lung Neoplasms
Radiofrequency ablation
Pulmonary Metastasis
Primary Pulmonary Neoplasms
Lead sponsor: Hangzhou Broncus Medical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-06
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is a multicenter, single group target value clinical trial to evaluate the safety and effectiveness of radiofrequency ablation for peripheral lung tumors under the conjunction of the pulmonary radiofrequency ablation system with the disposable pulmonary radiofrequency ablation catheter developed by Hangzhou Broncus Medical Co., Ltd.

Detailed description: The subjects will first undergo interventional bronchoscopy to reach the target lesion through the bronchial pathway. Then the lung lesions will be treated with radiofrequency ablation using the pulmonary radiofrequency ablation system and the disposable pulmonary radiofrequency ablation catheter. During the study, eligible subjects will be followed up intraoperatively, 24 hours after operation, before discharge/ 7 days after operation (whichever occurs first), 30 days (±7 days) after operation, 3 months (±7 days) after operation, 6 months (±15 days) after operation, 9 months (±15 days) after operation, and 12 months (±15 days) after operation.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old;
2. Planned ablated main lesions are pathologically confirmed and other planned ablated lesions are pathologically confirmed or clinical evaluated as primary NSCLC or pulmonary metastasis, and the primary lesions of lung metastasis subjects has been well controlled;
3. Number of unilateral lung lesions: ≤ 3 (excepting for multiple primary lung cancers);
4. Each lung lesion in size: ≤3 cm ;
5. Subjects refuse surgery or are considered intolerant of surgery;
6. Subjects refuse or are considered unsuitable for radiotherapy/chemotherapy, or are non-responders for previous radiotherapy/chemotherapy, or has disease progression after radiotherapy/chemotherapy;
7. It is feasible to arrive at the target lesions through bronchus path and carry out ablation operations, assessed by investigators;
8. Subjects whose Eastern oncology cooperative group (ECOG) physical state score: ≤3;
9. Subjects agree to undergo radiofrequency ablation to treat pulmonary lesions.

Exclusion Criteria:

1. Subjects with severe bleeding tendency and irreversible clotting disorders; or subjects who have stopped anticoagulation therapy and/or antiplatelet drugs for less than 7 days before ablation;
2. Subjects whose preoperative examination within 1 month shows intrathoracic lymph node or extra-pulmonary metastasis (except for extra-pulmonary metastasis controlled by local therapy);
3. Planned ablated lesions have received radiotherapy within past 6 months;
4. Subjects with high-risk disease for ablation operation;
5. The nearest distance between the tumors and trachea, main bronchial tube, esophagus, aortic arch branch, main pulmonary artery, left and right pulmonary artery and the heart is less than 2cm;
6. Subjects who have participated in the last 30 days or is participating in other clinical studies;
7. Subjects who are pregnant or have pregnancy plan during the study;
8. Subjects with bronchoscopy contraindications;
9. Subjects with implantable cardiac pacemakers, implantable defibrillators, or other active implants;
10. Subjects with general anesthesia contraindications;
11. Subjects with other conditions that need to be excluded as determined by investigators.

Primary outcomes:
measure: Complete ablation rate of main lesions at 6 months
timeFrame: Six months
Secondary outcomes:
measure: Technical success rate (in terms of ablation operations)
timeFrame: Immediately after Each Operation
measure: Complete ablation rate at 6 months (in terms of ablation lesions)
timeFrame: Six months
measure: Complete ablation rate at 6 months (in terms of subjects)
timeFrame: Six months
measure: Intrapulmonary progression-free survival rate at 6 months
timeFrame: Six months
measure: Complete ablation rate at 12 months (in terms of ablation lesions)
timeFrame: Twelve months
measure: Complete ablation rate at 12 months (in terms of subjects)
timeFrame: Twelve months
measure: Intrapulmonary progression-free survival rate at 1 year
timeFrame: Twelve months
measure: Overall survival rate (OS) at 1 year
timeFrame: Twelve months
measure: Quality of life (QoL)
timeFrame: Twelve months
measure: Safety
timeFrame: Twelve months
Other outcomes:
Locations:
city: Beijing
country: China
facility: The First Hospital of Peking University
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Shiyue Li, MD
role: PRINCIPAL_INVESTIGATOR
References: