Safety and Effectiveness of MPCD Therapy on the Treatment of Malignant Pleural Effusion (NCT04131231) | Clinical Trial Compass
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Safety and Effectiveness of MPCD Therapy on the Treatment of Malignant Pleural Effusion
248 participantsStarted 2019-10-15
Plain-language summary
This is a prospective, open-label , multicenter randomized controlled trial, with 248 cases in 50 centers planned for a period of 2 years. The aim of the study is to evaluate the safety and effectiveness of microparticles packaging chemotherapeutic drugs (MPCD) therapy on the treatment of malignant pleural effusion (MPE) in patients with advanced lung cancer or breast cancer.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed as lung cancer or breast cancer;
✓. Cytologically or histologically confirmed MPE needing thoracocentesis treatment;
✓. Without thoracocentesis treatment within 4 weeks;
✓. ECOG PS score: 0-2 points;
✓. Predicted life expectancy greater than 3 months;
✓. 18 years ≤Age ≤80 years；
✓. Bone marrow function: hemoglobin(HGB) ≥90g/L，white blood cells(WBC) ≥3.0×10\^9/L，absolute neutrophil count(ANC) ≥1.5×10\^9/L，platelets (PLT) ≥80×10\^9/L，international standardized ratio (INR) \<1.5;
✓. Hepatic function：alanine aminotransferase(ALT) and aspartate aminotransferase(AST) ≤2.5×ULN，serum total bilirubin≤1.5× ULN;
Exclusion criteria
✕. Inappropriate to receive chemotherapy;
✕. Women who are pregnant, preparing to be pregnant, breastfeeding;
✕. Known or suspected hypersusceptibility to any agents used in the treatment protocol;
✕. With severe cardiac disease, respiratory disease, liver disease, kidney disease, or diabetes;