Malignant Pleural Effusion
Conditions
Interventions
PP+MTX-microparticles intrapleural infusion group:PP+MTX-microparticles intrapleural infusion
PP+Normal saline intrapleural infusion group:PP+Normal saline intrapleural infusion
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed as lung cancer with malignant pleural effusion; 2. Advanced non-small cell lung cancer except squamous cell carcinoma is confirmed by pathology, with cancer cell in pleural effusion by pleural fluid cytology; 3. Stable vital sign with Karnofsky index (KPS - Karnofsky Performance Status) more than 70; 4. 18-70 years old; 5. Normal bone marrow hematopoietic function, no bleeding, blood routine: HGB >=90g/L, WBC >4.0*10^9/L; (NEU>=1.5*10^9/L), PLT>=100*10^9/L; 6. Liver function: total bilirubin <=1.5ULN; AST?ALT<=2.5ULN; Alkaline phosphatase<=1.5ULN; 7. BUN within 1.5 time upper limit of normal; Creatinine clearance rate more than 80mL/min; 8. Normal ECG, normal blood sugar levels; 9. Agreed to participate in the study and sign an informed consent; 10. Without other severe comorbidities.
Exclusion criteria
Exclusion criteria: 1. With chemotherapy treatment; 2. With local injection treatment in Pleural; 3. Pregnant or lactating patients; 4. Allergy to multiple drugs; 5. With other severe comorbidities or psychological diseases; 6. Severe infection; 7. Cognitive dysfunction; 8. Participation in other clinical trials within the recent three months; 9. Not available to participate in this clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pleural effusions volum; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate of target tumor;disease control rate;Overall survival;Progression-Free-Survival;Quality of Life; | — |
Countries
China
Contacts
Public ContactGang Wu,Yangg
Outcome results
None listed