malignant pleural effusion
Conditions
Interventions
A:brucea javanica oil emulsion
B:CDDP
C:brucea javanica oil emulsion combined with CDDP
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Diagnosis of clinical symptoms of malignant pleural effusion with pleural effusion cytology; 2) Age above 18 years old; 3) ECOG performance status: 0-2; 4) The expected survival longer than 3 months; 5) The main organ function normal, in accordance with the following standards: 5.1) Blood routine examination, in accordance with the following standards; a. Hb more than 9.0g/dL; b. WBC more than 4.0*10^9/L; c. ANC more than 1.5*10^9/L; ALB more than 30g/L; d. PLT more than 75*10^9/L; 5.2) Biochemical examination, in accordance with the following standards: a. BIL less than 1.25*ULN; b. ALT and AST less than 2.5 times of the upper limit of normal (ULN); c. Serum creatinine less than 1.5 ULN, creatinine clearance rate more than 60ml/min; 6) The patient voluntarily joined this study and signed informed consents, good compliance; 7) The time interval of the big operation less than 4 weeks; 8) Without intrapleural injection of anticancer drugs or hardening agent in a month.
Exclusion criteria
Exclusion criteria: 1) Merger failed to control the transfer of the central nervous system, manifestation of intracranial hypertension; 2) Patients have the bleeding phenomenon, the obvious gastrointestinal bleeding in 4 weeks, or for treatment of thrombolysis or anticoagulation; 3) Patient used other study drug in 30 days, or participated in other clinical research at the same time; 4) Patient had a myocardial infarction in 6 months, or had unstable angina; 5) Merger severe chronic obstructive pulmonary disease and/or respiratory failure; 6) Large volume of bilateral pleural effusion or wrapped pleural effusion; 7) The patients have poor compliance or mental illness and can't control themselves; 8) Allergic to the drug or pharmaceutical excipients of this study; 9) The patient has unable to control severe infection at present; 10) Female patients during pregnancy or lactation, patients of childbearing age resistant to using contraception (including male).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective response rate of pleural effusion in the 42th day;The control rate of pleural effusion in six month;Median effusion-free survival of the pleural effusion patient;Dyspnea VAS score in the 21th day and the 42th day; | — |
Secondary
| Measure | Time frame |
|---|---|
| The security of intervention; | — |
Countries
China
Contacts
Public ContactRenjie Yang
Outcome results
None listed