Non-small cell lung cancer with malignant pleural effusion
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participate voluntarily and sign informed consent with good compliance and can cooperate with diagnosis, treatment and follow-up; 2. Age >=18, male or female; 3. Diagnosis of NSCLC by histopathological and/or cytological examination, clinical stage IV (according to the TNM Staging System for Lung Cancer, 8th Edition of the International Association for the Study of Lung Cancer and the Joint Committee on American Classification of Cancer), with symptomatic malignant pleural effusion; 4. ECOG performance score 0-1 after discharge of pleural effusion; 5. Expected survival >=3 months; 6. The functions of the main organs are basically normal.
Exclusion criteria
Exclusion criteria: 1. Untreated BMS (patients who have received prior treatment for BMS [radiotherapy or surgery], who have been stable for at least 4 weeks on pre-randomized imaging and have stopped systemic hormone therapy [prednisone > 10mg/ day or other hormone equivalents] and who have no clinical symptoms can be enrolled); 2. With meningeal metastasis and spinal cord compression; 3. Bilateral pleural effusion is malignant pleural effusion; 4. Non-retractable pleural effusion (that is, the lung is still in the collapse state after thoracic tube drainage and cannot be retracted); Encapsulated compartmentalized pleural effusion; 5. Chest infection; There was skin infection at the site of thoracic catheterization; 6. Has not recovered to grade <=1 from any adverse event caused by any intervention prior to initial administration (except for hypotricia, hearing loss, and neurologic or endocrine disorders requiring substitution therapy, grade <=2); 7. Other conditions that the researcher considers inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pleural fixation rate;Progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;1 year overall survival rate;Change in dyspnea score;Safety; | — |
Countries
China
Contacts
West China Hospital of Sichuan University