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Efficacy of Argon-Helium Cryoablation Combined With PD-1 Inhibitors in Non-Small Cell Lung Cancer: A Randomized Controlled Trial
This randomized controlled trial investigated the efficacy and safety of argon-helium cryoablation combined with PD-1 inhibitors compared to PD-1 inhibitors plus chemotherapy for treating non-small cell lung cancer (NSCLC). The study aimed to evaluate differences in survival, tumor response, immune function, and adverse events.
This was a single-center, open-label, randomized controlled trial conducted at the First Hospital of Hebei Medical University, China. Sixty patients with advanced non-small cell lung cancer (NSCLC) were enrolled between December 2020 and December 2023. Patients were randomly assigned (1:1) to either a study group (argon-helium cryoablation combined with PD-1 inhibitor, Camrelizumab) or a control group (PD-1 inhibitor, Camrelizumab, combined with platinum-based doublet chemotherapy). Argon-helium cryoablation was performed prior to PD-1 inhibitor administration in the study group. Both groups received 4 cycles of systemic therapy. The primary endpoints were overall survival (OS) and progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), changes in immune function markers (CD4+, CD8+, CD4+/CD8+ ratio), and adverse reactions. Patients were followed for up to 1 year. The study aimed to determine if combining cryoablation with PD-1 inhibition offers superior outcomes compared to standard chemo-immunotherapy in NSCLC.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
the First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Start Date
December 1, 2020
Primary Completion Date
December 1, 2024
Completion Date
December 1, 2024
Last Updated
July 8, 2025
60
ACTUAL participants
Argon-Helium Cryoablation
DEVICE
Camrelizumab
DRUG
Platinum-based doublet chemotherapy
DRUG
Lead Sponsor
The First Hospital of Hebei Medical University
NCT06305754
NCT05920356
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06128551