Efficacy of Argon-Helium Cryoablation Combined With PD-1 Inhibitors in Non-Small Cell Lung Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Argon-Helium Cryoablation (Device)
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).
干预措施: Camrelizumab (Drug)
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.
干预措施: Camrelizumab (Drug)
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.
干预措施: Platinum-based doublet chemotherapy (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: 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)
时间窗: 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.
次要结局
- 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).)
- 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).)
- 1-year Progression-Free Survival Rate(At 1 year from randomization.)
研究者
Na Li
Principal investigator
The First Hospital of Hebei Medical University