Non Small Cell lung cancer patients with severe airway obstruction
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female in-patients, aged 18 to 83 years old; 2. NSCLC patients with severe airway obstruction;Definition of severe airway obstruction:Trachea: More than 1/2 of Trachea was obstructed by tumor; and/or block more than 2/3 of primary bronchi, right and middle bronchi; 3. lung cancer confirmed by histopathology; 4. With a airway tumor suitable for intratumoral injection via fiberoptic bronchoscope; 5. At least one measurable tumor could be evaluated by imaging examination (fiberoptic bronchoscope, CT, MRI or X-ray) according to the RECIST; 6. LT >=100,000/mm3; 7. Able to understand and comply with protocol and give written consent.
Exclusion criteria
Exclusion criteria: 1. With brain metastases; 2. With cardiovascular disease history: congestive heart-failure >NYHA grade II. Patients with unstable angina pectoris (angina pectoris symptoms occur at rest) or recent angina pectoris (occured in recent 3 months) or with myocardial infarction in recent 6 months must be excluded; 3. Severe uncontrollable infections or dysbolism; 4. Poor hepatic functional reserve or serious hepatocirrhosis, abnormal blood coagulation indicators; 5. Poor general conditions or cachexia; 6. The target tumors have been treated with radiotherapy within 6 months; 7. Pregnancy, breast-feeding women; 8. Known hypersensitivity to PTS or related compounds; 9. Lung cancer focus not suitable for local treatment; 10. Any other reasons deemed reasonable by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary Function;Overall survival; | — |