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

NCT07053215 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-08

No results posted yet for this study

Summary

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.

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Interventions

DEVICE

Argon-Helium Cryoablation

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.

DRUG

Camrelizumab

200 mg intravenously every 3 weeks for 4 cycles.

DRUG

Platinum-based doublet chemotherapy

* 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.

Sponsors & Collaborators

  • The First Hospital of Hebei Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07053215 on ClinicalTrials.gov