Status:
UNKNOWN
Safety and Effectiveness of MPCD Therapy on the Treatment of Malignant Pleural Effusion
Lead Sponsor:
Peking Union Medical College
Conditions:
Lung Cancer
Breast Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 effectiven...
Detailed Description
After obtaining informed consent, patients who meet the eligibility criteria will be randomly assigned 1:1 to treatment either with MPCD or recombinant human interleukin-2(rhIL-2) for injection. Rando...
Eligibility Criteria
Inclusion
- 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;
- Renal function：blood urea nitrogen(BUN) and serum creatinine(Cr) ≤1.5×ULN, or endogenous creatinine clearance rate(Ccr) ≥60mL/min;
- Without other severe cardiac disease or respiratory disease;
- The volunteers voluntarily join the study, sign informed consent, and have good compliance and follow-up.
Exclusion
- 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;
- With severe infection;
- With severe encapsulated pleural effusion or intrathoracic tissue adhesion which is inappropriate to receive thoracocentesis;
- With cognitive impairment or low compliance;
- Participating in other clinical trials within 4 weeks;
- Undergoing immunotherapy within 3 months;
- Other conditions considered to be inappropriate to be enrolled by the investigator.
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2021
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT04131231
Start Date
October 15 2019
End Date
June 15 2021
Last Update
October 18 2019
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