The goal of this observational study is to evaluate the performances of a percutaneous Pulsed Electrical Field (PEF) ablation to treat patients with primary early-stage lung cancer (NSCLC) or lung oligometastatic Tumors who are unresectable or refusal surgery/Radiotherapy.
The main questions the study aims to answer are:
The safety and technical feasibility of the PEF ablation. The preliminary efficacy of the PEF ablation for target lesion in lung
Patients who meet the inclusion/exclusion criteria will be given percutaneous PEF ablation to the target lesions under general anesthesia. Then follow-up to 12 months to monitor any progression by about 3 months interval.
Target Subject： Patients with early-stage primary non-small cell lung cancer(NSCLC) or pulmonary oligometastatic tumors who are not surgical resectable or unsuitable for surgery/radiotherapy
Age ≥18 years but ≤ 79 years, male or female
Pathologically diagnosed primary NSCLC and stage IA, or oligometastatic lung tumors that primary cancer has been controlled. the maximum diameter of the lesion is ≤3cm, (Pathological diagnosis includes conventional pathological examination or ROSE rapid on-site evaluation)
For multiple primary lung cancers, the number of lesions is ≤3 and the maximum diameter of the lesion(s) is ≤3cm. For metastatic tumors, the number of lesions in one side of lung is ≤3 (total lesions in both sides <5), the maximum diameter of the lesion(s) is ≤3cm.
ECOG score ≤ 2;
Received any form of local tumor therapy for the target lung tumor lesion(s) within 6 months.
Currently receiving systemic anti-tumor therapy, such as chemotherapy, targeted therapy, immunotherapy etc.
The distance between tumor lesion edge and important structures such as heart, diaphragm and mediastinum is less than 10mm.
With a history of hypersensitivity to medications to be used in general anesthesia or drugs required during the procedure/follow-up (such as contrast-enhanced CT scan).
Single group
Pulsed Electric Field Ablation
DeviceApplication of Pulsed Electric Field energy to ablate the lung tumor through percutaneous approach.
The clinical safety of the device and/or procedure in the operation of PEF ablation and entire study follow-up.
Adverse events rate and severe adverse event rate related to the device and/or procedure during the ablation procedure and thereafter 12 months follow-Up
The success rate of the ablation procedure
The success rate of the procedure is defined as the proportion of ablation procedures in which the PEF treatment catheter is deployed to the target lesion and pulsed electrical field energy is delivered and then the catheter is withdrawn out from lung
The technical success rate of the PEF ablation
The technical success rate of the PEF ablation that is defined as the proportion of lesions where the CT imaging-assessed ablation zone (Post-ablation Target Zone, PTZ) is larger than the gross tumor region (GTR) at least 5 mm.
Complete ablation rate of the target lesions at 6-month and 12-month post the ablation.
Complete ablation of the target lesions is defined as to achieve the following criteria on contrast-enhanced CT images ① Lesion disappears; ② Complete cavity formation; ③ Lesion fibrosis, which may be a scar; ④ Lesion shrinks, remains unchanged, or enlarges, but shows no enhancement on contrast-enhanced CT and/or no metabolic activity on PET/CT; ⑤ Atelectasis, with the lesion within the atelectasis showing no contrast enhancement on CT and/or no metabolic activity on PET/CT. The baseline is defined as CT image of 4-6 weeks post the ablation.
Proportion of patients with target tumor progression free survival (PFS) at 6-month and 12-month.
The proportion of subjects without target lesion progression in lung at 6-month and 12-month post the PEF procedure in evaluative subjects.
Proportion of patients requiring initiation of any other anti-tumor interventions since PEF ablation up to 12 months.
Pulmonary function measures at 6-month and 12-month
The pulmonary function measures includes Forced Vital Capacity (FVC) in liter, Forced Expiratory Volume in the first second (FEV1) in liter, Ratio of FEV1/FVC in percentage, Total Lung Capacity (TLC) in liter, Residual Volume (RV) in liter, Ratio of RV/TLC in percentage and Diffusing Capacity of the Lungs for Carbon Monoxide(DLCO) in ml/mmHg/min and the percentages of all of the measures compared with the predicted value accordingly at 6-month and 12-month post procedure.
Quality of Life assessed at 3-month, 6-month and 12-month.
EORTC QLQ-C30(European Organisation for Research and Treatment of Cancer Quality of Life, The Core Questionnaire) and EORTC QLQ-LC13 (European Organisation for Research and Treatment of Cancer Quality of Life, Lung Cancer Questionnaire) be used to assess the quality of life. EORTC QLQ-C30(version 3.0) include global health status, functional scale and symptom scales/items. The range of the score is from zero to 100 points. For functional and global health status, the higher score mean a better conditions. For symptom domain, the higher score reversely indicates worse status. EORTC QLQ-LC13 is designed to assess the quality of life in patient with lung cancer. The range of score is from zero to 100 points. The higher score mean the worse symptoms.
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