Traditional Chinese Medicine Combined With Thermal and Cold Ablation for Early-stage Lung Cancer

Study Overview
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Brief Summary
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Lung cancer is the leading cause of cancer related mortality. At present, surgical treatment is the main choice for early-stage lung cancer. Even after surgery, the 5-year recurrence rate is still as high as 18.4%-24%. Traditional Chinese medicine combined with thermal and cold 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 evaluate the efficacy of traditional Chinese medicine combined with thermal and cold ablation for patients with stage I non-small cell lung cancer.

Official Title
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A Prospective Open-Label Randomized Study of Traditional Chinese Medicine Combined With Thermal and Cold Ablation for Early-stage Lung Cancer

Conditions
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Non-small Cell Lung Cancer Stage I

Intervention / Treatment
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* Combination Product: traditional Chinese medicine and ablation in the primary tumor sites
* Procedure: ablation


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 lung nodule. Maximum diameter of lung nodule ≥8mm. The pathology of lung nodules biopsy was non-small cell lung cancer. I period according to the eighth edition of the TNM staging period. No mediastinal lymph node metastasis. Eastern Cooperative Oncology Group performance status of 0 to 1. No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments. Sufficient organ functions. Exclusion Criteria: Patients with previous use of various hormones, immunosuppression or autoimmune diseases. Women during pregnancy or breast-feeding. Patients with severe heart, lung, kidney disease or other systemic diseases Patients with severe hemorrhagic diseases. Patients with a history of drug abuse or mental illness. Other conditions that the investigator has determined are not suitable for participation in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: traditional Chinese medicine combined with thermal or cold ablation<br> | Combination Product: traditional Chinese medicine and ablation in the primary tumor sites<br>* Patients will be treated with traditional Chinese medicine and ablation in the primary tumor sites<br>|
| Active Comparator: thermal or cold ablation<br> | Procedure: ablation<br>* Patients will be treated with ablation in the primary tumor sites<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | Response were evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee. BEST RESPONSE from the start of study treatment until the end of treatment were reported. Objective response rate is the sum of CR + PR divided by the total number of patients in each group. | 2 years after ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS | The time interval from the first medication to the observation of recurrence or metastasis, or death from any cause (calculated based on the previous event). Patients who have not relapsed, metastasized or died at the time of the data cutoff, and those who were lost to follow-up in the study will be counted on the date of their last tumor evaluation. | 2 years after ablation |