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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Ospedaliero Universitaria Pisana

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-12-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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

Secondary objectives 2

1. To evaluate the safety of the PITAC method for the surgical treatment of patients with MPE. For this purpose, the demographic, clinical, pathological characteristics, intra- and postoperative variables, and any complications of patients enrolled in the study will be recorded and analyzed
2. To evaluate the oncologic efficacy of the PITAC method for loco-regional (intrapleural) disease

Conditions and MedDRA coding

Pleural carcinosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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.

Exclusion criteria 1

1. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 1

1. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Ospedaliero Universitaria Pisana

Sponsor organisation

Azienda Ospedaliero Universitaria Pisana

Address

Via Paradisa 2

City

Pisa

Postcode

56124

Country

Italy

Scientific contact point

Organisation

Azienda Ospedaliero Universitaria Pisana

Contact name

Clinical Trial Center

Public contact point

Organisation

Azienda Ospedaliero Universitaria Pisana

Contact name

Clinical Trial Center

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications