Clinical trial NCT04889989: Microwave Ablation in Chinese Patients With Lung Tumors
Official title: A Single-Arm, Prospective, Multicenter Study to Evaluate the Effectiveness and Safety of the NeuWave Certus Microwave Ablation System in Chinese Patients With Primary or Secondary Tumors in the Lung
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer of the Lung
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-18
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm, prospective, multicenter clinical trial with a performance goal
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Signed the informed consent form and willing to fulfill the study-related assessments and procedure schedule.
2. Lung tumor patients ≥ 18 years of age who are ineligible for/decline surgery and who plan to receive microwave ablation therapy.
3. ECOG performance status score of 0-2.
4. Patients with stages IA1-IA2 NSCLC with documented results from a biopsy or patients with clinically diagnosed oligometastatic lung tumor.
5. 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.
6. 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:

1. Pregnant or breast-feeding.
2. Patients with implantable pacemakers or other electronic implants.
3. Oligometastatic tumors patients whose primary lesion cannot be controlled or have widely metastases, in the opinion of the investigator and/or treating oncologist.
4. Any planned concurrent procedure at the time of ablation.
5. Planned treatment for other tumors in the same side lung during the study period.
6. With a skin infection or ulceration at the site to be punctured by probe(s).
7. Clinical or imaging findings consistent with an active pulmonary infection.
8. Patients with severe pulmonary fibrosis in the area intended to ablate, especially drug-induced pulmonary fibrosis.
9. Patients with prior radiotherapy in the area intended to ablate.
10. Patients with uncontrolled malignant pleural effusion at the lung side with tumor to ablate.
11. Tumors where the anticipated zone of ablation would encompass significant (in the opinion of the treating physician) emphysematous or bullous disease.
12. The investigator anticipates that the ablation zone of the multiple tumor(s) to be ablated may have overlapping ablation zones.
13. 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.
14. 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.
15. Patients with uncorrectable coagulopathy based on investigator judgment.
16. Patients with a platelet count ≤ 50 × 109/L.
17. 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.
18. 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.
19. Patients who cannot discontinue warfarin before at least 5 days before the ablation procedure of the study or have an INR \> 1.5.
20. As judged by the investigator, the patient has hypertension that cannot be effectively controlled by pharmacological treatments.
21. 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.
22. Expected survival less than 6 months.
23. Participation in any other interventional clinical study within 30 days before screening.
24. Physical or psychological condition which would impair study participation.
25. Patient is judged unsuitable for study participation by the investigator for any other reason.

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

Primary outcomes:
measure: Technical Efficacy Rate
timeFrame: 30 days (+/- 7 days) post-ablation
Secondary outcomes:
measure: Technical Success Rate
timeFrame: Ablation Day (day 0)
measure: Local Tumor Progression
timeFrame: 1 year post-ablation
measure: Overall Survival
timeFrame: 1-year post-ablation
measure: Progression-Free Survival
timeFrame: 1-year post-ablation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Pecking University Shenzhen Hospital
city: Fujian
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
city: Henan
country: China
facility: Henan Cancer Hospital
city: Hunan
country: China
facility: Hunan Cancer Hospital
city: Shandong
country: China
facility: Qilu Hospital of Shandong University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Hospital
Study officials:
References: