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 1:1 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
134
Patients undergo cryoablation.
Patients undergo cryoablation. If there are no significant postoperative complications, Serplulimab should be administered immediately. Cycles with Serplulimab repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
3-year progression-free survival (PFS)
This refers to the length of time between the participant's first onset of disease progression or death from any cause after treatment.
Time frame: 3 years
1-year, 2-year, and 3-year Objective Response Rate (ORR)
The percentage of patients that achieve complete response (CR) and partial response (PR) after treatment.
Time frame: 3 years
Overall Survival (OS)
The time from the start of treatment to the patient's death or the last follow-up, with a maximum observation period of 5 years from randomization.
Time frame: 5 years
Incidence of Adverse Events
Adverse events include those related to the cryoablation procedure occurring during or after the procedure, as well as drug-related adverse events caused by immunotherapy.
Time frame: 1 year
Potential Predictive and Immunological Biomarkers (lymphocyte phenotypes, PD-L1 expression, cytokines)
This refers to the changes from baseline in the immunological responses following the cryoablation (with or without Serplulimab) and comparison between the two groups, including the percentage and function of lymphocyte phenotypes, the expression of PD-L1, the concentration of IFN-γ levels, etc.
Time frame: 1 year
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