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

NCT03448146 Phase 3 COMPLETED

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.

Details

Lead sponsor	PTS International Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	90
Start date	2009-08
Completion	2011-12

Conditions

• Nsclc

Interventions

• Para-Toluenesulfonamide

Primary outcomes

• Objective response rate — 30 days after the last treatment
  The objective response rate of target lesions in patients with central air way NSCLC tumor severe obstruction after PTS treatment were evaluated based on measurement results of CT and bronchoscopy.
• Improvement rate of luminal obstructions — 30 days after the last treatment
  The improvement rate of luminal obstructions in patients with central air way NSCLC tumor severe obstruction after PTS treatment were evaluated based on measurement results of CT and bronchoscopy.

Countries

China