{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T20:19:44Z","timestamp":1790713184303,"version":"4.1.0"},"reference-count":14,"publisher":"Walter de Gruyter GmbH","issue":"2","license":[{"start":{"date-parts":[[2018,6,1]],"date-time":"2018-06-01T00:00:00Z","timestamp":1527811200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2018,6,26]]},"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n Nanoparticles hold considerable promise for aerosol-based intraperitoneal delivery in patients with carcinomatosis. Recently, results from preclinical and early clinical trials suggested that albumin-bound paclitaxel (ABP, Abraxane\u2122) may result in superior efficacy in the treatment of peritoneal metastases (PM) compared to the standard solvent-based paclitaxel formulation (Taxol\u2122). Here, we propose a phase I study of pressurized intraperitoneal aerosol chemotherapy (PIPAC) using ABP in patients with upper Gastrointestinal, breast, or ovarian cancer.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n Eligible patients with advanced, biopsy-proven PM from ovarian, breast, gastric, hepatobiliary, or pancreatic origin will undergo three PIPAC treatments using ABP with a 4-week interval. The dose of ABP will be escalated from 35 to 140\u2006mg\/m\u00b2 using a Bayesian approach until the maximally tolerated dose is determined. The primary end point is dose-limiting toxicity. Secondary analyses include surgical morbidity, non-access rate, pharmacokinetic and pharmacodynamic analyses, quality of life, and exploratory circulating biomarker analyses.<\/jats:p>\n <\/jats:sec>\n \n Discussion<\/jats:title>\n ABP holds considerable promise for intraperitoneal aerosol delivery. The aim of this study is to determine the dose level for future randomized phase II trials using ABP in PIPAC therapy.<\/jats:p>\n <\/jats:sec>\n \n Trial registration<\/jats:title>\n This trial is registered as EudraCT: 2017-001688-20 and Clinicaltrials.gov: NCT03304210.<\/jats:p>\n <\/jats:sec>","DOI":"10.1515\/pp-2018-0112","type":"journal-article","created":{"date-parts":[[2018,6,8]],"date-time":"2018-06-08T18:17:31Z","timestamp":1528481851000},"source":"Crossref","is-referenced-by-count":30,"title":["Intraperitoneal aerosolization of albumin-stabilized paclitaxel nanoparticles (Abraxane\u2122) for peritoneal carcinomatosis \u2013 a phase I first-in-human study"],"prefix":"10.1515","volume":"3","author":[{"given":"Leen","family":"Van De Sande","sequence":"first","affiliation":[{"name":"Department of GI Surgery , Ghent University Hospital , Ghent , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Graversen","sequence":"additional","affiliation":[{"name":"Department of Surgery , Odense University Hospital , Odense , Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Hubner","sequence":"additional","affiliation":[{"name":"Department of Visceral Surgery , Lausanne University Hospital , Lausanne , Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Pocard","sequence":"additional","affiliation":[{"name":"Digestive and Cancer Surgical Unit , Lariboisi\u00e8re Hospital , Paris , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Reymond","sequence":"additional","affiliation":[{"name":"Department of Surgery and Transplantation , University Hospital , Tuebingen , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Vaira","sequence":"additional","affiliation":[{"name":"Candiolo Cancer Institute , Torino , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Cosyns","sequence":"additional","affiliation":[{"name":"Department of GI Surgery , Ghent University Hospital , Ghent , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wouter","family":"Willaert","sequence":"additional","affiliation":[{"name":"Department of GI Surgery , Ghent University Hospital , Ghent , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wim","family":"Ceelen","sequence":"additional","affiliation":[{"name":"Department of GI Surgery , Ghent University Hospital , Ghent , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2018,6,8]]},"reference":[{"key":"2025120909215701287_j_pp-2018-0112_ref_001_w2aab3b7b3b1b6b1ab1b4b1Aa","doi-asserted-by":"crossref","unstructured":"Huang CQ, Min Y, Wang SY, Yang XJ, Liu Y, Xiong B, et al. 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