2024-511255-17-00撤回2 期
Pressurized intrathoracic aerosol chemotherapy (PITAC) in patients with malignant pleural effusion: a single-center phase II trial. PITAC_ MaPEPi
Azienda Ospedaliero Universitaria Pisana1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年12月22日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PITAC efficacy will be evaluated in terms of pleurodesis and therefore of the control of the entity of MPE volume at 1, 3 and 6 months after the surgical procedure. Therapeutic efficacy will be assessed according to the criteria of the WHO for the treatment response of MPE after surgery. In this study, the effective objective response in terms of pleurodesis after PITAC will include CR and PR.
研究概览
简要总结
To evaluate the efficacy of pleurodesis performed by PITAC, using the World Health Organization (WHO) criteria for the assessment of response after surgical treatment in patients with MPE
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis (positive preoperative cytological exam of pleural fluid) or high clinical-radiological suspicion of primary or secondary pleural carcinosis requiring surgery (using VATS) for diagnostic and/or staging purposes and pleurodesis intent (in suspected cases, pathologic confirmation will be obtained by intraoperative frozen section); Patients between 18 and 80 years of age; Performance status according to ECOG ≤ 2, suitable for general anesthesia; Life expectancy of at least 3 months; Patients who are not candidates for any exclusive or combined standard cytoreductive treatment; Written informed consent; Using effective methods of contraception. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception as per the CTFG guidance on contraception (version 1.2), starting during study screening visit. Female patients of childbearing age will be included in the study and monitored by pregnancy testing before PITAC procedure.
排除标准
- •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
结局指标
主要结局
PITAC efficacy will be evaluated in terms of pleurodesis and therefore of the control of the entity of MPE volume at 1, 3 and 6 months after the surgical procedure. Therapeutic efficacy will be assessed according to the criteria of the WHO for the treatment response of MPE after surgery. In this study, the effective objective response in terms of pleurodesis after PITAC will include CR and PR.
PITAC efficacy will be evaluated in terms of pleurodesis and therefore of the control of the entity of MPE volume at 1, 3 and 6 months after the surgical procedure. Therapeutic efficacy will be assessed according to the criteria of the WHO for the treatment response of MPE after surgery. In this study, the effective objective response in terms of pleurodesis after PITAC will include CR and PR.
次要结局
- The safety of PITAC measured in terms of complications and mortality. For this purpose, intra- and post-operative variables will be recorded, in addition to the demographic and clinical characteristics of the study population. Mortality at 30- and 90-days from the surgical procedure will be recorded
研究者
Clinical Trial Center
Scientific
Azienda Ospedaliero Universitaria Pisana
研究点 (1)
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