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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Cryoablation 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
Hunan Cancer hospital
Changsha, Hunan, China
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
Time frame: Time from first dose to last dose, or up to 24 month
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
Time frame: Time from first dose to last dose, or up to 24 month
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
Time frame: Time from first subject dose to study completion, or up to 36 month
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%
Time frame: Time from first subject dose to study completion, or up to 36 month
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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Time frame: Time from first subject dose to study completion, or up to 36 month
Progression-free survival
Progression-free survival of patients treated with cryoablation plus immunochemotherapy was assessed according to the Investigator Response Evaluation criteria (RECIST) version 1.1, defined as the duration of first documented disease progression or death from any cause
Time frame: Time from first subject dose to study completion, or up to 36 month
Overall survival
To assess overall survival, it was defined as the first dose at which the subject died from any cause
Time frame: Time from first subject dose to study completion, or up to 36 month
Adverse events
Number of participants with adverse events (AEs) according to CTCAE 5.0
Time frame: Time from first subject dose to study completion, or up to 36 month
Life quality score
Score according to EORTC QLQ-L30+QLQ-LC13 table
Time frame: Time from first subject dose to study completion, or up to 36 month