Pressurized intrathoracic aerosol chemotherapy (PITAC) in patients with malignant pleural effusion: a single-center phase II trial. PITAC_ MaPEPi

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• Impaired cardiac function (history of congestive heart failure or FE <40%). Clinically significant cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrolment), myocardial infarction (<6 months prior to enrolment), unstable angina, congestive heart failure (New York Heart Association Classification Class > II or serious uncontrolled cardiac Arrhythmia requiring medication; Impaired renal function (creatinine> 1.5 upper limit of normal or creatinine clearance <60 mL / min); Impaired hepatic function (AST, ALT >2.5 upper limit of normal, bilirubin> 1.5 upper limit of normal); Impaired hematopoietic function (leucocytes <4000/mm3, neutrophils <1500 / mm3, platelets <100000/ mm3); History or presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of PITAC or patient at high risk from treatment complications; Psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation; Participants with newly diagnosed active/latent TB or HBV/HCV/HIV; Myelosuppression; Ongoing infections; Known hypersensitivity to chemotherapeutic agents; Contraindications and/or hypersensitivity to surgery and/or general anesthesia; Patients with age < 18 and > 80 years, subjects who are incapacitated; Pregnant or nursing (breastfeeding) women; Patients who do not speak and understand national language