An interventional study of Argon-Helium Cryoablation and Camrelizumab in Non-small Cell Lung Cancer (NSCLC), sponsored by The First Hospital of Hebei Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by The First Hospital of Hebei Medical University · Not applicable, Interventional, and Treatment
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 60 is close to the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →The First Hospital of Hebei Medical University is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients received argon-helium cryoablation followed by PD-1 inhibitor (Camrelizumab 200 mg IV every 3 weeks for 4 cycles).
Device: Argon-Helium Cryoablation · Drug: Camrelizumab
Patients received PD-1 inhibitor (Camrelizumab 200 mg IV every 3 weeks) combined with standard platinum-based doublet chemotherapy for 4 cycles.
Drug: Camrelizumab · Drug: Platinum-based doublet chemotherapy
Procedure performed within 7 days before the first dose of PD-1 inhibitor. CT-guided insertion of cryoprobes into the target tumor. Two freeze-thaw cycles: rapid freeze to -135°C to -145°C for 15-20 minutes, followed by thawing.
200 mg intravenously every 3 weeks for 4 cycles.
* Non-squamous NSCLC: Pemetrexed (500 mg/m² IV on day 1) plus Carboplatin (AUC 5 mg/mL•min IV on day 1) of each 3-week cycle. * Squamous NSCLC: Gemcitabine (1250 mg/m² IV on days 1 and 8) plus Carboplatin (AUC 5 mg/mL•min IV on day 1) of each 3-week cycle. * Administered for 4 cycles.
Overall Survival (OS)
Time from randomization to death from any cause.
Time frame: From randomization until death, assessed through study completion, an average of 1 year.
Progression-Free Survival (PFS)
Time from randomization to disease progression (RECIST 1.1) or death from any cause, whichever occurred first.
Time frame: From randomization until disease progression or death, assessed through study completion, an average of 1 year.
Objective Response Rate (ORR)
Proportion of patients achieving Complete Response (CR) or Partial Response (PR) according to mRECIST criteria.
Time frame: Assessed after 4 cycles of treatment (each cycle is 21 days), at approximately 12 weeks from randomization.
Disease Control Rate (DCR)
Proportion of patients achieving CR, PR, or Stable Disease (SD) according to mRECIST criteria.
Time frame: Assessed after 4 cycles of treatment (each cycle is 21 days), at approximately 12 weeks from randomization.
Change in CD4+ T lymphocyte counts
Change in peripheral blood CD4+ T lymphocyte subset counts from baseline.
Time frame: Baseline (Day 1, prior to treatment) and at the end of Cycle 4 (each cycle is 21 days).
Change in CD8+ T lymphocyte counts
Change in peripheral blood CD8+ T lymphocyte subset counts from baseline.
Time frame: Baseline (Day 1, prior to treatment) and at the end of Cycle 4 (each cycle is 21 days).
Change in CD4+/CD8+ T lymphocyte ratio
Change in the ratio of peripheral blood CD4+ to CD8+ T lymphocytes from baseline.
Time frame: Baseline (Day 1, prior to treatment) and at the end of Cycle 4 (each cycle is 21 days).
Incidence and severity of Adverse Events (AEs)
Number and grade of AEs according to NCI-CTCAE v5.0.
Time frame: From the first dose of study treatment until 30 days after the last dose of study medication (up to approximately 16 weeks).
1-year Progression-Free Survival Rate
Proportion of patients alive and without disease progression at 1 year from randomization.
Time frame: At 1 year from randomization.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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