Malignant Pleural Effusion
Conditions
Interventions
experimental group:Human lung carcinoma cell-derived microparticles packaging methotrexate intrapleural infusion
Control group:Cisplatin intrapleural infusion
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed as lung cancer or clinical diagnosis, confirmed MPE needing thoracocentesis treatment; 2. Patients who have undergone surgery, systemic chemoradiotherapy or recurrence according to conventional clinical treatment plan; Or for their own reasons unconditionally implement the conventional treatment plan, give up the conventional clinical treatment plan. 3. ECOG PS score: 0-2 points; 4. Predicted life expectancy greater than 3 months; 5. Aged 18-75 years; 6. Bone marrow function: hemoglobin(HGB)>=90g/Lwhite blood cells(WBC)>=3.0x10^9/Labsolute neutrophil count(ANC) >=1.5 x 10^9 /Lplatelets, (PLT) >= 80 x 10^9/L, international standardized ratio (INR) < 1.5; 7. Without other severe cardiac disease or respiratory disease; 8. The volunteers voluntarily join the study, sign informed consent, and have good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, preparing to be pregnant, breastfeeding; 2. Known or suspected hypersusceptibility to any agents used in the treatment protocol; 3. With severe cardiac disease, respiratory disease, liver disease, kidney disease, or diabetes; 4. With severe infection; 5. With severe encapsulated pleural effusion or intrathoracic tissue adhesion which is inappropriate to receive thoracocentesis; 6. With cognitive impairment or low compliance; 7. Participating in other clinical trials within 4 weeks; 8. Other conditions considered to be inappropriate to be enrolled by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective response rate of pleural effusion in the 4 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| The control rate of pleural effusion in three month;Overall survival;Tumor markers in serum and pleural effusionr;Characters of pleural effusion;Characters of pleural effusion;The security of intervention; | — |
Countries
China
Contacts
Public ContactYang Jin
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Outcome results
None listed