A Trial of PTS Via Intratumoral Injection in Patients With Central Air Way NSCLC Severe Obstruction

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PTS International Inc.

Criteria

Inclusion Criteria:

• Male or female inpatients, aged 18 to 83 years old.

• Patients with central air way non-small cell lung cancer (NSCLC) severe obstruction; definition of severe airway obstruction: ≥1/2 trachea is obstructed by tumor; and/or block ≥2/3 of primary bronchi, right and middle bronchi. And the longest diameter of the lesion > 0.5 cm.

• Pathologically confirmed lung cancer.

• Patients with tracheal tumor lesions suitable for local intratumoral injection via fibro-bronchoscopy.

• At least one measurable lesion that could be evaluated by imaging examination (bronchoscopy, CT, MRI or X-ray etc.) according to the Response Evaluation Criteria in Solid Tumors.

• Blood platelet count ≥ 100,000/mm3.

• Subjects who were able to understand and comply with the trial protocol and give written consent.

Exclusion Criteria:

• Brain metastases.

• History of cardiovascular diseases, including congestive heart failure > New York Heart Association (NYHA) Grade II. Patients with unstable angina pectoris (angina pectoris symptoms at rest), recent angina pectoris (occurred in the recent 3 months) or with myocardial infarction in recent 6 months must be excluded.

• Severe infections or dysbolism.

• Poor hepatic functional reserve or severe hepatocirrhosis, with abnormal blood coagulation indicators.

• Poor general conditions or cachexia.

• The target lesion had been treated with radiotherapy within 6 months.

• Pregnant or breast-feeding woman.

• Known hypersensitivity to PTS or related compounds.

• Lung cancer lesions not suitable for local treatment.

• Any other reason deemed reasonable by the investigator.