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The purpose of the study is to evaluate the efficacy and safety of multimode thermal therapy for early peripheral lung cancer, and to explore the changes of systemic immune microenvironment after multimode thermal therapy.
This is a single-center, single-arm, exploratory study, and is expected to enroll a total of 10 patients. The enrolled patients were stage IA lung cancer patients with lung lesions found on chest CT, pathologically diagnosed as non-small cell lung cancer, negative for driver gene mutations, and who were considered high-risk or refused surgery by multidisciplinary evaluation. Follow-ups are performed after the multimode thermal therapy. The primary endpoint is complete ablation rate at 6 months after multimode thermal therapy. The secondary endpoints are complete ablation rate at 12 months after multimode thermal therapy, local control rate at 1, 2, 3 years post-procedure, progression-free survival and mmune effects after multimodal thermal therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimode thermal therapy | Experimental | Percutaneous multimode thermal therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimode thermal therapy | Device | The multimode thermal therapy procedure consists of a sequential rapid freezing, natural thawing, and radio-frequency (RF) heating of the target tumor tissue. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete ablation rate at 6 months post-procedure | This refers to the proportion of completely ablated lesions in the total ablated lesions at 6 months after multimode thermal therapy. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete ablation rate at 12 months post-procedure | This refers to the proportion of completely ablated lesions in the total ablated lesions at 12 months after multimode thermal therapy. | 12 months |
| Local control rate at 1, 2, 3 years post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayuan Sun | Contact | +86-021-22200000 | 1511 | jysun1976@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiayuan Sun | Shanghai Chest Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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multimode thermal therapy
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This refers to the proportion of completely and incompletely ablated lesions in the total ablated lesions at 1 year, 2 years and 3 years after multimode thermal therapy.
| 3 years |
| Progression-free survival | This refers to the length of time between the participant's first onset of disease progression or death from any cause after multimode thermal therapy. | 3 years |
| Immunological response (lymphocyte phenotypes, PD-L1 expression, cytokines) | This refers to the changes from baseline in the immunological responses following the multimode thermal therapy, including the percentage and function of lymphocyte phenotypes, the expression of PD-L1, the concentration of IL-6/IL-17A levels, etc. | 3 months |
| Number of participants with adverse events | This refers to all treatment-related adverse events (grade 1- 5) occurring during the trial and follow-up period as assessed by CTCAE v5.0. | 1 month |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |