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.
Adult oncology
Gastrointestinal tumours
Gynaecological oncology
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
05 01 2023
05 01 2023
Historique:
entrez:
5
1
2023
pubmed:
6
1
2023
medline:
10
1
2023
Statut:
epublish
Résumé
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. 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/m 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. NCT04000906.
Identifiants
pubmed: 36604127
pii: bmjopen-2022-067691
doi: 10.1136/bmjopen-2022-067691
pmc: PMC9827272
doi:
Substances chimiques
Cisplatin
Q20Q21Q62J
130-nm albumin-bound paclitaxel
0
Doxorubicin
80168379AG
Aerosols
0
Banques de données
ClinicalTrials.gov
['NCT04000906']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e067691Informations de copyright
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared for IL-G, FR, MU, AD, PP, CT, MDM and NM. MH declares the following competing interests: ENCARE Consultant fee (institution); Nestlé; Research funding Capnomed Sponsoring of scientific meetings MSD; Fresenius Speaker honorary (institution); ERAS society Board member, chair education; ISSPP Board member, chair education.
Références
Eur J Cancer. 2009 Jan;45(2):228-47
pubmed: 19097774
Clin Cancer Res. 2021 Apr 1;27(7):1830-1832
pubmed: 33472909
Rev Med Suisse. 2015 Jun 17;11(479):1325-30
pubmed: 26255492
N Engl J Med. 2018 Jan 18;378(3):230-240
pubmed: 29342393
Cancer Sci. 2010 Oct;101(10):2128-36
pubmed: 20860602
Clin Cancer Res. 2021 Apr 1;27(7):1875-1881
pubmed: 33148667
Gynecol Oncol. 2015 May;137(2):223-8
pubmed: 25701703
Cancer Sci. 2018 Nov;109(11):3575-3582
pubmed: 30281875
Ann Surg Oncol. 2014 Feb;21(2):553-9
pubmed: 24006094
Lancet Oncol. 2019 Jul;20(7):e368-e377
pubmed: 31267971
J Ovarian Res. 2014 Feb 08;7:19
pubmed: 24507759
Eur J Surg Oncol. 2017 Jun;43(6):1102-1109
pubmed: 28431896
Eur J Surg Oncol. 2018 Jul;44(7):991-996
pubmed: 29526367
Ann Surg Oncol. 2013 Jul;20(7):2311-6
pubmed: 23377563
Cancer Immunol Res. 2017 Mar;5(3):182-190
pubmed: 28108630
Gynecol Oncol. 2017 Mar;144(3):480-485
pubmed: 28089377
EBioMedicine. 2022 Aug;82:104151
pubmed: 35843174
Gynecol Oncol. 2018 Jul;150(1):23-30
pubmed: 29743140
Ann Surg Oncol. 2013 Oct;20(11):3504-11
pubmed: 23765417
Br J Surg. 2017 May;104(6):669-678
pubmed: 28407227
Clin Cancer Res. 2006 Feb 15;12(4):1317-24
pubmed: 16489089
Gastroenterol Res Pract. 2017;2017:6852749
pubmed: 28331493
Cancer Treat Rev. 2016 Nov;50:129-141
pubmed: 27665540
Eur J Surg Oncol. 2021 Jan;47(1):11-35
pubmed: 32199769
J Clin Oncol. 2001 Feb 15;19(4):1001-7
pubmed: 11181662
Lancet Gastroenterol Hepatol. 2017 Apr;2(4):277-287
pubmed: 28404157
BMB Rep. 2013 Mar;46(3):131-8
pubmed: 23527856
Gynecol Oncol. 2013 Feb;128(2):221-8
pubmed: 22960352
J Cancer. 2018 Jan 1;9(1):13-20
pubmed: 29290765
Gastric Cancer. 2016 Oct;19(4):1052-1065
pubmed: 26621525
Ann Surg. 2004 Aug;240(2):205-13
pubmed: 15273542
Cancer Sci. 2014 Jul;105(7):812-7
pubmed: 24716542
Cancer Treat Res. 1996;82:359-74
pubmed: 8849962
Cancer Chemother Pharmacol. 2019 Mar;83(3):589-598
pubmed: 30623229
Gastroenterol Res Pract. 2017;2017:4596176
pubmed: 28316621
Pleura Peritoneum. 2016 Jun 1;1(2):99-107
pubmed: 30911613
Gynecol Oncol. 2011 Jul;122(1):111-5
pubmed: 21497382
Ann Surg Oncol. 2006 Aug;13(8):1156-61
pubmed: 16791447
Ann Gastroenterol. 2018 Jan-Feb;31(1):65-70
pubmed: 29333068
Cancer Treat Rep. 1978 Jan;62(1):1-11
pubmed: 626987
Biomedicines. 2020 Apr 30;8(5):
pubmed: 32365877
Nat Rev Dis Primers. 2021 Dec 16;7(1):91
pubmed: 34916522
PLoS One. 2012;7(12):e51039
pubmed: 23251419