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.
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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.
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.
Single group
Sintilimab, Nab-Paclitaxel, and Carboplatin
DrugCryoablation received at least 2 or more depending on the mass, with 2-3 cycles；Sintilimab 200 mg Q3W plus Nab-Paclitaxel 260mg / m2(Day 1) Q3W + carboplatin AUC 4.25 or 5 (Day 1) Q3W, 4 cycles，until 24 months
Objective Response Rate of Airway Tumor
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
Pathological Response Rate of Airway Obstruction
The pathologic response rate of airway tumors obstruction in patients treated with cryoablation combined with immunochemotherapy was evaluated according to the investigator which was defined as the proportion of subjects with endoscopically assessed airway pathologic residual tumors ≤10% after treatment recorded for the first or last time after cryoablation
Airway Obstruction Response Control Rate
The DCR for airway tumors obstruction in patients treated with cryoablation combined with immunochemotherapy was assessed according to the investigator's RECIST 1.1, defined as the proportion of subjects evaluated for complete (CR) + partial response (PR) and stable SD for intraairway tumors after the first recorded treatment
FEV1R improvement rate of airway obstruction
Calculated according to the subjects' pulmonary function measures assessed by the investigator: FEV1 (post-treatment) -FEV1 (pre-treatment)/FEV1 (pre-treatment) \*100%
Airway Obstruction Response Duration
The duration of response in subjects with CR or PR was assessed according to the Solid Tumor Response Assessment Criteria (RECIST) version 1.1 developed by the investigators, defined as the time from the first recorded evaluated airway tumor CR or PR to airway disease progression or death
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