Efficacy of Argon-Helium Cryoablation Plus PD-1 Inhibitors in NSCLC

Sponsor
The First Hospital of Hebei Medical University
Study ID
NCT07053215
Status
Completed

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Argon-Helium Cryoablation — DEVICE
    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.
  • Camrelizumab — DRUG
    200 mg intravenously every 3 weeks for 4 cycles.
  • Platinum-based doublet chemotherapy — DRUG
    * 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.

Study Details

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.

Key Dates

Start date
Dec 1, 2020
Status verified
Jun 2025
Primary completion
Dec 1, 2024
Completion
Dec 1, 2024

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Argon-Helium Cryoablation + PD-1 Inhibitor
    Patients received argon-helium cryoablation followed by PD-1 inhibitor (Camrelizumab 200 mg IV every 3 weeks for 4 cycles).
  • Active Comparator: PD-1 Inhibitor + Chemotherapy
    Patients received PD-1 inhibitor (Camrelizumab 200 mg IV every 3 weeks) combined with standard platinum-based doublet chemotherapy for 4 cycles.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From randomization until death, assessed through study completion, an average of 1 year. ]

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