Cryoablation
ProcedurePatients undergo cryoablation.
NCT Number: NCT06580665
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 years
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
The percentage of patients that achieve complete response (CR) and partial response (PR) after treatment.
Time frame: 5 years
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: 1 year
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
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.
Contact information is provided by the study sponsor or research team.
Shanghai Chest Hospital
Other
Randomized Clinical Trials Comparing Immunotherapy Plus Cryoablation (I-CA) Versus Cryoablation Alone for Stage I, Selected Stage IIa, Non-Small Cell Lung Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07630168
Bronchial Neoplasms, Carcinoma
Chapel Hill, North Carolina, United States
View Trial DetailsNCT07720167
Bronchial Neoplasms, Carcinoma, Bronchogenic
Charleston, South Carolina, United States
View Trial DetailsNCT07680790
Bronchial Neoplasms, Carcinoma, Bronchogenic
Beverly Hills, California, United States
View Trial DetailsNCT07699757
Advanced Solid Tumors, Bronchial Neoplasms
Shanghai, Shanghai Municipality, China
View Trial Details