Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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Lung cancer is the leading cause of cancer related mortality. Among them, non small cell lung cancer accounts for 85%. Only part of patients could be treated with radical surgery. Mitochondria-targeted system therapy combined with radiofrequency ablation could be an alternative treatment. Small sample clinical cases verified that this therapy could be an efficacy and safe treatment in a short period. The primary aim of this trial is to determine if the efficacy of mitochondria-targeted system therapy combined with radiofrequency ablation is comparable to that of standard surgical interventions for patients with non-small cell lung cancer.

Official Title
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Prospective Clinical Study of Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Other: Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation
* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient can understand and voluntarily join the study, sign the informed consent form, and the compliance is good. Patients with single nodule. Before IIB period according to the eighth edition of the TNM staging period. No mediastinal lymph node metastasis. No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments. Eastern Cooperative Oncology Group performance status of 0 to 1 Sufficient organ functions Exclusion Criteria: Active bacterial or fungous infection. Simultaneous or metachronous (within the past 5 years) double cancers. Patients with contraindications to radiofrequency ablation and inability to complete treatment; Women during pregnancy or breast-feeding. Uncontrollable diabetes mellitus. Patients with severe heart, lung, kidney disease or other systemic diseases who have been judged to have a severe impact on survival or who are pre-assessed to be unable to tolerate thoracoscopic surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitochondrial therapy with radiofrequency ablation<br> | Other: Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation<br>* Patients will be treated with mitochondria-targeted system therapy and radiofrequency ablation in the primary tumor sites<br>|
| Active Comparator: Surgery<br> | Procedure: Surgery<br>* Patients will be treated with surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | From the date of randomization until the date of first documented progression，assessed up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | From the date of randomization until the date of death from any cause，assessed up to 60 months |