Nsclc Clinical Trial
Official title:
A Phase III Single Arm Trial of PTS (Para Toluenesulfonamide Injection) Via Bronchoscopy Intervention Intratumoral Injection in Patients With Central Air Way NSCLC Tumor Severe Obstruction
This trial was to evaluate the efficacy of intratumoral PTS injection in alleviating airway obstruction and dyspnea by improving the percentage of lumen patency of patients with central air way NSCLC tumor severe obstruction.
1. Local intratumoral injection of para toluenesulfonamide (PTS) via bronchoscopy could
alleviate airway obstruction for patients with central air way NSCLC tumor severe
obstruction, which contributed to the shrinkage of target tumor lesions in a short
period, with an objective response rate of 66% and an improvement rate of luminal tumor
obstruction of 70% in the end-of-treatment period.
2. Patient's pulmonary function, atelectasis and quality of life were improved
significantly after treatment, indicating that PTS treatment cuold relieve the symptoms
of air way obstruction and provide clinical benefits to the patients.
3. Adverse events were mainly blood streaked sputum, injection site haemorrhage, cough,
pyrexia and oropharyngeal pain, without reporting of potential risks. Common study drug
related adverse events included injection site haemorrhage, cough, and blood streaked
sputum and oropharyngeal pain. The multi-center clinical study conducted strictly in
accordance with Standard Operation Procedures for the Use of a Standard Bronchoscope in
Local Intratumoral PTS Injection showed that PTS had good safety and tolerability and
that the procedural risks of intratumoral PTS injection via bronchoscopy could be
controlled.
4. The advantages of PTS for treatment of airway lung cancer obstruction included
significant efficacy, good safety, large applicable population; relatively simple
equipment conditions and operation, thus it could be spread easily. PTS is also expected
to be used in the treatment of central lung cancer with acute airway obstruction in
combination with other treatments (such as stent implantation), which provides a new
drug treatment to patients with airway lung cancer obstruction. PTS can complement with
other treatments, which is expected to improve the treatment efficacy significantly.
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