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Scientific article
Open access
English

Nab-PIPAC: a phase IB study protocol of intraperitoneal cisplatin and nab-paclitaxel administered by pressurised intraperitoneal aerosol chemotherapy (PIPAC) in the treatment of advanced malignancies confined to the peritoneal cavity

Published inBMJ open, vol. 13, no. 1, e067691
First online date2023-01-05
Abstract

Introduction: Intraperitoneal dissemination is a major problem resulting in very poor prognosis and a rapid marked deterioration in the quality of life of patients. Pressurised intraperitoneal aerosol chemotherapy (PIPAC) is an emergent laparoscopic procedure aiming to maximise local efficacy and to reduce systemic side effects.

Methods and analysis: Nab-PIPAC, a bicentre open-label phase IB, aims to evaluate safety of nab-paclitaxel and cisplatin association using in patients with peritoneal carcinomatosis (PC) of gastric, pancreatic or ovarian origin as ≥1 prior line of systemic therapy. Using a 3+3 design, sequential intraperitoneal laparoscopic application of nab-paclitaxel (7.5, 15, 25, 37.5, 52.5 and 70 mg/m2) and cisplatin (10.5 mg/m2) through a nebuliser to a high-pressure injector at ambient temperature with a maximal upstream pressure of 300 psi. Treatment maintained for 30 min at a pressure of 12 mm Hg and repeated4-6 weeks intervals for three courses total.A total of 6-36 patients are expected, accrual is ongoing. Results are expected in 2024.The primary objective of Nab-PIPAC trial is to assess tolerability and safety of nab-paclitaxel and cisplatin combination administered intraperitoneally by PIPAC in patients with PC of gastric, pancreatic or ovarian origin. This study will determine maximum tolerated dose and provide pharmacokinetic data.

Ethic and dissemination: Ethical approval was obtained from the ethical committees of Geneva and Vaud (CCER-2018-01327). The study findings will be published in an open-access, peer-reviewed journal and presented at relevant conferences and research meetings.

Trial registration number: NCT04000906.

eng
Keywords
  • Adult oncology
  • Gastrointestinal tumours
  • Gynaecological oncology
  • Humans
  • Cisplatin / therapeutic use
  • Peritoneal Cavity / pathology
  • Doxorubicin
  • Quality of Life
  • Aerosols
  • Peritoneal Neoplasms / drug therapy
  • Peritoneal Neoplasms / pathology
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Clinical Trials, Phase I as Topic
Funding
  • Hôpitaux Universitaires de Genève - Young investigator research and development project [PRD 9-2019-I]
Citation (ISO format)
LANG, Noémie et al. Nab-PIPAC: a phase IB study protocol of intraperitoneal cisplatin and nab-paclitaxel administered by pressurised intraperitoneal aerosol chemotherapy (PIPAC) in the treatment of advanced malignancies confined to the peritoneal cavity. In: BMJ open, 2023, vol. 13, n° 1, p. e067691. doi: 10.1136/bmjopen-2022-067691
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Article (Published version)
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Identifiers
ISSN of the journal2044-6055
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Technical informations

Creation01/17/2023 9:24:00 AM
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