Malignant Pleural Effusion
Conditions
Interventions
Group 1:systemic chemotherapy +MTX-microparticles intrapleural infusion
Group 2:systemic chemotherapy +Interleukin - 2 intrapleural infusion
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed as lung cancer or breast cancer or clinical diagnosis, confirmed MPE needing thoracocentesis treatment; 2. Without thoracocentesis treatment within 2 weeks;or recently, thoracentesis and drainage have been carried out, but no thoracentesis and catheterization has been carried out more than 2 weeks before this puncture, and CT imaging examination has been carried out within 3 days before this puncture and drainage; 3. ECOG PS score: 0-2 points; 4. Predicted life expectancy greater than 3 months; 5. 18 years =Age =80 years 6. Bone marrow function: hemoglobin(HGB) =90g/Lwhite blood cells(WBC) =3.0×10^9/Labsolute neutrophil count(ANC) =1.5×10^9/Lplatelets (PLT) =80×10^9/L,international standardized ratio (INR) <1.5; 7. Hepatic function:alanine aminotransferase(ALT) and aspartate aminotransferase(AST) =2.5×ULN,serum total bilirubin=1.5× ULN; 8. Renal function:blood urea nitrogen(BUN) and serum creatinine(Cr) =1.5×ULN, or endogenous creatinine clearance rate(Ccr) =60mL/min; 9.Without other severe cardiac disease or respiratory disease; 10. The volunteers voluntarily join the study, sign informed consent, and have good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Inappropriate to receive chemotherapy; 2. Women who are pregnant, preparing to be pregnant, breastfeeding; 3. Known or suspected hypersusceptibility to any agents used in the treatment protocol; 4. With severe cardiac disease, respiratory disease, liver disease, kidney disease, or diabetes; 5. With severe infection; 6.With severe encapsulated pleural effusion or intrathoracic tissue adhesion which is inappropriate to receive thoracocentesis; 7. With cognitive impairment or low compliance; 8. Participating in other clinical trials within 4 weeks; 9. 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 ;Progression-Free-Survival;Overall survival;The security of intervention ;Quality of Life;Characters of pleural effusion;The control rate of hydrothorax in the first systemic efficacy evaluation;; | — |
Countries
China
Contacts
Public ContactFei Ma
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed