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

NCT ID: NCT07053215

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2024-12-01

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.

Detailed Description

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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Argon-Helium Cryoablation

Intervention Type: 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

Intervention Type: DRUG

200 mg intravenously every 3 weeks for 4 cycles.

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.

Group Type: ACTIVE_COMPARATOR

Camrelizumab

Intervention Type: DRUG

200 mg intravenously every 3 weeks for 4 cycles.

Platinum-based doublet chemotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Camrelizumab

200 mg intravenously every 3 weeks for 4 cycles.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Na Li

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

GZ2023116

Identifier Type: -

Identifier Source: org_study_id