Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453889
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-25
Brief Title:
Efficacy and Safety of Multimode Thermal Therapy in the Treatment of Early Peripheral Lung Cancer
Sponsor:
Shanghai Chest Hospital
Organization:
Shanghai Chest Hospital
Study Overview
Official Title:
Efficacy and Safety of Multimode Thermal Therapy in the Treatment of Early Peripheral Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None