{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T04:33:38Z","timestamp":1789187618237,"version":"build-2803163510"},"reference-count":47,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2023,1,5]],"date-time":"2023-01-05T00:00:00Z","timestamp":1672876800000},"content-version":"unspecified","delay-in-days":4,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"H\u00f4pitaux Universitaires de Gen\u00e8ve \u201cYoung investigator research and development project\u201d","award":["PRD 9-2019-I"],"award-info":[{"award-number":["PRD 9-2019-I"]}]},{"name":"Division of gynecology, HUG","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]},{"name":"Division of visceral surgery, HUG","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]},{"name":"Fondation pour l\u2019innovation sur le cancer et la biologie","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]},{"name":"Fond\u2019action contre le cancer","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]},{"name":"Department of oncology, CHUV","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]},{"name":"Division of visceral surgery, CHUV","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]},{"name":"Clinical research unit (DFDL) of the department of oncology","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,12,16]]},"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      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 \u22651 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\u2009mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      ) and cisplatin (10.5\u2009mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      ) through a nebuliser to a high-pressure injector at ambient temperature with a maximal upstream pressure of 300 psi. Treatment maintained for 30\u2009min at a pressure of 12\u2009mm Hg and repeated4\u20136 weeks intervals for three courses total.\n                    <\/jats:p>\n                    <jats:p>A total of 6\u201336 patients are expected, accrual is ongoing. Results are expected in 2024.<\/jats:p>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethic and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04000906\">NCT04000906<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-067691","type":"journal-article","created":{"date-parts":[[2023,1,5]],"date-time":"2023-01-05T10:43:02Z","timestamp":1672915382000},"page":"e067691","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":16,"title":["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"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct04000906","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04000906","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1243-4888","authenticated-orcid":false,"given":"Noemie","family":"Lang","sequence":"first","affiliation":[{"name":"Service d'oncologie, D\u00e9partement d'Oncologie, H\u00f4pitaux Universitaires de Gen\u00e8ve, Gen\u00e8ve, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonella","family":"Diciola","sequence":"additional","affiliation":[{"name":"Service d'oncologie, D\u00e9partement d'Oncologie, Centre Hospitalier Universitaire Vaudois, Lausanne, 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