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

Not Applicable

Completed

• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Interventions: Device: Argon-Helium Cryoablation; Drug: Camrelizumab; Drug: Platinum-based doublet chemotherapy

• Registration Number: NCT07053215
• Lead Sponsor: The First Hospital of Hebei Medical University

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.

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-19
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Argon-Helium Cryoablation + PD-1 Inhibitor	Argon-Helium Cryoablation	Patients received argon-helium cryoablation followed by PD-1 inhibitor (Camrelizumab 200 mg IV every 3 weeks for 4 cycles).
Argon-Helium Cryoablation + PD-1 Inhibitor	Camrelizumab	Patients received argon-helium cryoablation followed by PD-1 inhibitor (Camrelizumab 200 mg IV every 3 weeks for 4 cycles).
PD-1 Inhibitor + Chemotherapy	Camrelizumab	Patients received PD-1 inhibitor (Camrelizumab 200 mg IV every 3 weeks) combined with standard platinum-based doublet chemotherapy for 4 cycles.
PD-1 Inhibitor + Chemotherapy	Platinum-based doublet 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 Measures

Name	Time	Method
Overall Survival (OS)	From randomization until death, assessed through study completion, an average of 1 year.	Time from randomization to death from any cause.
Progression-Free Survival (PFS)	From randomization until disease progression or death, assessed through study completion, an average of 1 year.	Time from randomization to disease progression (RECIST 1.1) or death from any cause, whichever occurred first.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Assessed after 4 cycles of treatment (each cycle is 21 days), at approximately 12 weeks from randomization.	Proportion of patients achieving Complete Response (CR) or Partial Response (PR) according to mRECIST criteria.
Disease Control Rate (DCR)	Assessed after 4 cycles of treatment (each cycle is 21 days), at approximately 12 weeks from randomization.	Proportion of patients achieving CR, PR, or Stable Disease (SD) according to mRECIST criteria.
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 peripheral blood CD4+ T lymphocyte subset counts from baseline.
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 peripheral blood CD8+ T lymphocyte subset counts from baseline.
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).	Change in the ratio of peripheral blood CD4+ to CD8+ T lymphocytes from baseline.
Incidence and severity of Adverse Events (AEs)	From the first dose of study treatment until 30 days after the last dose of study medication (up to approximately 16 weeks).	Number and grade of AEs according to NCI-CTCAE v5.0.
1-year Progression-Free Survival Rate	At 1 year from randomization.	Proportion of patients alive and without disease progression at 1 year from randomization.

Trial Locations

Locations (1)

the First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China