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

NCT07053215 | Completed DMC

• 1 other identifier: GZ2023116
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Argon-helium cryoablation; PD-1 inhibitor; Non-small cell lung cancer; Randomized controlled trial; Efficacy; Immune function

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  Time from randomization to death from any cause.

  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.

  From randomization until disease progression or death, assessed through study completion, an average of 1 year.

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  Assessed after 4 cycles of treatment (each cycle is 21 days), at approximately 12 weeks from randomization.

• Disease Control Rate (DCR)

  Assessed after 4 cycles of treatment (each cycle is 21 days), at approximately 12 weeks from randomization.

• Change in CD4+ T lymphocyte counts

  Baseline (Day 1, prior to treatment) and at the end of Cycle 4 (each cycle is 21 days).

• Change in CD8+ T lymphocyte counts

  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

  Baseline (Day 1, prior to treatment) and at the end of Cycle 4 (each cycle is 21 days).

Study Arms (2)

Argon-Helium Cryoablation + PD-1 Inhibitor

EXPERIMENTAL

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

PD-1 Inhibitor + Chemotherapy

ACTIVE COMPARATOR

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

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.

Argon-Helium Cryoablation + PD-1 Inhibitor

Camrelizumab DRUG

200 mg intravenously every 3 weeks for 4 cycles.

Argon-Helium Cryoablation + PD-1 Inhibitor; PD-1 Inhibitor + Chemotherapy

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.

PD-1 Inhibitor + Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed NSCLC, stage IIIB, IIIC, or IV (AJCC 8th Edition);
• At least one measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
• Estimated survival time ≥6 months;
• Receiving argon-helium cryoablation combined with PD-1 inhibitor for the first time at our institution (for study group) or standard chemo-immunotherapy (for control group);
• Unable or unwilling to undergo surgical resection for various reasons;
• Karnofsky Performance Status (KPS) score ≥60;
• Conscious and capable of effective communication;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.

You may not qualify if:

• Presence of other active malignant tumors;
• Significant uncontrolled hepatic (total bilirubin \>1.5 × upper limit of normal \[ULN\], AST/ALT \>2.5 × ULN or \>5 × ULN if liver metastases present) or renal dysfunction (creatinine clearance \<50 mL/min);
• Non-primary NSCLC (i.e., metastatic from another site);
• Known allergy or contraindication to study drugs or inability to comply with the treatment plan;
• Coexisting active tuberculosis, uncontrolled systemic infections, or other significant pulmonary diseases that would interfere with treatment or outcome assessment;
• Pregnancy or lactation;
• Severe psychiatric disorders;
• Uncorrected coagulation disorders (e.g., INR \>1.5 or platelet count \<75 × 109/L);
• Known immunodeficiency syndromes (e.g., HIV infection);
• Symptomatic hemorrhagic pleural effusion requiring urgent intervention;
• Patients who withdrew consent before randomization or were deemed non-compliant by investigators.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

the First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 8, 2025
• Study Start: December 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 8, 2025

Record last verified: 2025-06

Locations

CN (1)