The Efficacy and Safety of Bronchoscopic Cryoablation Combined With Sintilimab Plus Platinum-based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic NSCLC With Central Airway Obstruction: A Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Objective Response Rate of Airway Tumor
研究概览
简要总结
This study aimed to evaluate the efficacy and safety of bronchoscopic cryoablation combined with sintilimab plus platinum-based chemotherapy as First-line Treatment for locally advanced or metastatic NSCLC with central airway obstruction.
详细描述
This is a prospective interventional clinical study to evaluate the efficacy and safety of bronchoscopic cryoablation combined with sintilimab plus platinum-based chemotherapy as First-line Treatment for locally advanced or metastatic Non-small Cell Lung Cancer with central airway obstruction.
Approximately 39 patients with locally advanced or metastatic NSCLC and central airway obstruction, without EGFR-sensitive mutations (19del, L858R, and T790M), were enrolled and treated with bronchoscopic cryoablation combined with Sintilimab, Nab-Paclitaxel, and Carboplatin until disease progression, intolerable toxicity, or meeting the criteria for discontinuation of the trial drug.
The primary endpoint is the investigator-assessed objective response rate (ORR) of airway tumors. Secondary endpoints include the pathological response rate (PRR) of airway tumors, disease control rate (DCR), improvement rate of FEV1, duration of response (DOR) for airway tumors, progression-free survival (PFS), overall survival (OS), quality of life assessment, and safety. Recruitment for the study is expected to begin in mainland China around October 2024, with the trial anticipated to conclude in October 2027.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand the requirements and contents of the clinical trial and provide a signed and dated informed consent form.
- •Age≥18 years and≤80 years.
- •Histologically or cytologically confirmed and documented locally advanced or metastatic non-small cell lung cancer (NSCLC) without prior systemic therapy and EGFR-sensitive mutations (19del, L858R and T790M).
- •Presence of a palliative treatment lesion in the central airway that is amenable to ablation, endoscopically assessed to be≥1/3 obstruction, such as primary or metastatic malignancy to the trachea, main bronchi, intermediate bronchi, or segmental bronchi. corresponding respiratory symptoms or obstructive pneumonia is permission to be included.
- •Eastern Cooperative Oncology Group (ECOG) ： 0-
- •Predicted survival ≥ 12 weeks.
- •Adequate bone marrow hematopoiesis and organ function (cardiac function, hepatic, and renal function).
- •Presence of measurable lesions according to RECIST 1.1 criteria.
- •Subjects with stable brain metastases may be included in the study.
排除标准
- •Histological diagnosis of small cell, large cell lung cancer; mixed tumors will be classified based on the primary cell type; if the primary component is small cell, large cell, or neuroendocrine carcinoma, the subject will not be eligible for enrollment; however, mixed adenocarcinoma-squamous cell carcinoma is acceptable. Subjects with driver gene mutations are generally not eligible for enrollment.
- •Malignant central airway obstruction with acute dyspnea or severe life-threatening symptoms of malignant airway stenosis, or assessed by the investigator to be unable to tolerate subsequent treatment; extrinsic airway compression; large pleural effusion, severe coughing, massive hemoptysis, dyspnea, or inability to cooperate; severely impaired lung function with a maximal voluntary ventilation (MVV) < 39% or inability to ambulate.
- •Prior systemic therapy for locally or metastatic disease.
- •Uncorrectable coagulation disorders, severe bleeding tendencies, platelet count < 50 *10^9/L, or severe coagulation dysfunction.
- •Presence of symptomatic brain metastases.
- •Known severe hypersensitivity to anti-PD-1 monoclonal antibodies or similar drugs (allergic reactions with CTCAE≥ grade 3 toxicity).
- •Subjects with persistent or active infection, including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV).
- •Any concurrent malignancy other than basal cell carcinoma or cervical carcinoma in situ. (Patients with a history of malignant tumors but with no evidence of disease for≥ 3 years may be included ).
- •Women who are breastfeeding or pregnant.
- •Other conditions assessed by the investigator to be unsuitable for participation in the study.
研究组 & 干预措施
group 1
Bronchial endoscopic cryoablation
干预措施: Sintilimab, Nab-Paclitaxel, and Carboplatin (Drug)
结局指标
主要结局
Objective Response Rate of Airway Tumor
时间窗: Time from first dose to last dose, or up to 24 month
The ORR for Objective response of airway tumors after cryoablation combined with immunochemotherapy was evaluated according to the investigator's Solid Tumor Response Assessment Criteria (RECIST) version 1.1, defined as the proportion of subjects who were evaluated for complete response (CR) + partial response (PR) to airway tumors after the first documented treatment
次要结局
- Pathological Response Rate of Airway Obstruction(Time from first dose to last dose, or up to 24 month)
- Airway Obstruction Response Control Rate(Time from first subject dose to study completion, or up to 36 month)
- FEV1R improvement rate of airway obstruction(Time from first subject dose to study completion, or up to 36 month)
- Airway Obstruction Response Duration(Time from first subject dose to study completion, or up to 36 month)
- Progression-free survival(Time from first subject dose to study completion, or up to 36 month)
- Overall survival(Time from first subject dose to study completion, or up to 36 month)
- Adverse events(Time from first subject dose to study completion, or up to 36 month)
- Life quality score(Time from first subject dose to study completion, or up to 36 month)
研究者
Yongchang Zhang
Head of Medical Oncology, Director of Early Clinical Trial Center
Hunan Province Tumor Hospital