Microwave Ablation in Chinese Patients With Lung Tumors

Not Applicable

Terminated

Conditions: Cancer of the Lung

Interventions: Device: Microwave Ablation

Registration Number: NCT04889989

Lead Sponsor: Ethicon, Inc.

Brief Summary: Adult patients with non-small cell lung cancer (NSCLC) or oligometastatic lung tumors will all receive microwave ablation (MWA) performed percutaneously by doctors who are experienced in lung tumor ablation. 120 patients will participate across 8 clinical study sites all in China.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 13

Inclusion Criteria

Signed the informed consent form and willing to fulfill the study-related assessments and procedure schedule.
Lung tumor patients ≥ 18 years of age who are ineligible for/decline surgery and who plan to receive microwave ablation therapy.
ECOG performance status score of 0-2.
Patients with stages IA1-IA2 NSCLC with documented results from a biopsy or patients with clinically diagnosed oligometastatic lung tumor.
Tumor(s) to be ablated in a single surgery should be a maximum of one NSCLC tumor or a maximum of three ipsilateral oligometastatic lung tumors.
Tumor(s) to be ablated in a single surgery should be ≤ 2cm, locate in the outer two-thirds of a lung, not closer than 1 cm from the hilum of lung, great vessels, principal bronchus, trachea or esophagus, and not contiguous with the pleura.

Exclusion Criteria

Pregnant or breast-feeding.
Patients with implantable pacemakers or other electronic implants.
Oligometastatic tumors patients whose primary lesion cannot be controlled or have widely metastases, in the opinion of the investigator and/or treating oncologist.
Any planned concurrent procedure at the time of ablation.
Planned treatment for other tumors in the same side lung during the study period.
With a skin infection or ulceration at the site to be punctured by probe(s).
Clinical or imaging findings consistent with an active pulmonary infection.
Patients with severe pulmonary fibrosis in the area intended to ablate, especially drug-induced pulmonary fibrosis.
Patients with prior radiotherapy in the area intended to ablate.
Patients with uncontrolled malignant pleural effusion at the lung side with tumor to ablate.
Tumors where the anticipated zone of ablation would encompass significant (in the opinion of the treating physician) emphysematous or bullous disease.
The investigator anticipates that the ablation zone of the multiple tumor(s) to be ablated may have overlapping ablation zones.
Patients who have received lung ablation or surgical resection therapy within 30 days prior to the ablation procedure under study and those who plan to receive lung tumor ablation or surgical resection therapy or radiation therapy on the ablated lung side before completing the primary efficacy endpoint assessment approximately 30 days after the ablation procedure.
Patients who received systemic therapy such as chemotherapy, targeted drug therapy, or immunotherapy within 7 days prior to the ablation procedure under study, and patients who had a systemic treatment plan such as chemotherapy, targeted drug therapy, immunotherapy, etc. before completing the primary efficacy endpoint assessment approximately 30 days after the ablation procedure.
Patients with uncorrectable coagulopathy based on investigator judgment.
Patients with a platelet count ≤ 50 × 109/L.
Patients who cannot discontinue antiplatelet medication (e.g., aspirin, clopidogrel, prasugrel, ticagrelor) at least 5 days before the ablation procedure through 24 hours post-procedure.
Patients who cannot discontinue anticoagulant medication (e.g., rivaroxaban, apixaban, dabigatran, edoxaban) at least 3 days before the ablation procedure through 24 hours post-procedure.
Patients who cannot discontinue warfarin before at least 5 days before the ablation procedure of the study or have an INR > 1.5.
As judged by the investigator, the patient has hypertension that cannot be effectively controlled by pharmacological treatments.
Severe hepatic, renal, cardiac, pulmonary or cerebral insufficiency, severe anemia, dehydration, and severe nutrition and metabolism disorders, which cannot be corrected or improved within a short term; or serious systemic infection; or severe neuromuscular diseases.
Expected survival less than 6 months.
Participation in any other interventional clinical study within 30 days before screening.
Physical or psychological condition which would impair study participation.
Patient is judged unsuitable for study participation by the investigator for any other reason.

Intra-Ablation Exclusion Criteria:
Before ablation probe puncture on the skin, patient is judged unsuitable for study participation due to intolerance to anesthesia.
Before ablation probe puncture on the skin, patient is judged unsuitable for study participation due to presenting any other condition.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Microwave Ablation of Lung Tumor	Microwave Ablation	Adult patients with non-small cell lung cancer (NSCLC) or oligometastatic lung tumors who plan to receive percutaneous microwave ablation.

Primary Outcome Measures

Name	Time	Method
Technical Efficacy Rate	30 days (+/- 7 days) post-ablation	Percentage of tumors that were completely covered by the ablation zone with no sign of pathological enhancement according to the lung contrast-enhanced CT assessment as assessed by the Independent Review Committee.

Secondary Outcome Measures

Name	Time	Method
Technical Success Rate	Ablation Day (day 0)	Percentage of tumors that achieve A0 or A1 ablation classification determinations (i.e., complete tumor ablation with a surrounding margin) based on the lung CT immediately following the initial ablation procedure and as assessed by the Independent Review Committee.
Local Tumor Progression	1 year post-ablation	Progression of disease to a tumor treated during the original microwave ablation procedure.
Overall Survival	1-year post-ablation	Rate of patients still alive 1-year post-ablation (includes lead-in participants so out of 13).
Progression-Free Survival	1-year post-ablation	Rate of patients still alive 1-year post-ablation without any sort of progression of disease (local, regional, or distant).

Trial Locations

Locations (8): Hunan Cancer Hospital
🇨🇳
Hunan, China
Beijing Hospital
🇨🇳
Beijing, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳
Harbin, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳
Fujian, China
Pecking University Shenzhen Hospital
🇨🇳
Beijing, China
Henan Cancer Hospital
🇨🇳
Henan, China
Qilu Hospital of Shandong University
🇨🇳
Shandong, China
Fudan University Shanghai Cancer Hospital
🇨🇳
Shanghai, China