Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580665
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
Cryoablation with or Without Serplulimab in Treating Patients with Stage I-IIA Non-small Cell Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Clinical Trials Comparing Immunotherapy Plus Cryoablation I-CA Versus Cryoablation Alone for Stage I Selected Stage IIa Non-Small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cryoablation is a minimally invasive technique that utilizes very low temperature to eliminate tumour cells for patients ineligible for surgery It has been reported that cryoablation may enhance immune response and synergize with immunotherapy
This study is a multicenter randomized controlled exploratory trial and is expected to enroll a total of 134 patients The enrolled patients were stage Ia Ib or IIa lung cancer with negative driver gene mutations who are considered high-risk for surgery or refuse surgery based on multidisciplinary evaluation Eligible patients will be randomly assigned in a 11 ratio to receive either cryoablation alone CA group or cryoablation combined with immunotherapy I-CA group The study aims to evaluate the safety and clinical benefits of combining immunotherapy with cryoablation in the treatment of early-stage NSCLC by comparing progression-free survival PFS objective response rate ORR overall survival OS and the incidence of adverse events between the two groups
This study is a multicenter randomized controlled exploratory trial and is expected to enroll a total of 134 patients The enrolled patients were stage Ia Ib or IIa lung cancer with negative driver gene mutations who are considered high-risk for surgery or refuse surgery based on multidisciplinary evaluation Eligible patients will be randomly assigned in a 11 ratio to receive either cryoablation alone CA group or cryoablation combined with immunotherapy I-CA group The study aims to evaluate the safety and clinical benefits of combining immunotherapy with cryoablation in the treatment of early-stage NSCLC by comparing progression-free survival PFS objective response rate ORR overall survival OS and the incidence of adverse events between the two groups
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None