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Clinical Trial
. 2024;20(33):2521-2531.
doi: 10.1080/14796694.2024.2394013. Epub 2024 Sep 12.

Safety of pressurized intraperitoneal aerosolized chemotherapy in biliary cancer patients with peritoneal metastases

Daneng Li  1 , Christiana Crook  1 , Vincent Chung  1 , Gagandeep Brar  1 , Marwan Fakih  1 , Afsaneh Barzi  1 , Laleh Melstrom  1 , Gagandeep Singh  1 , Yuman Fong  1 , Paul Frankel  2 , Mustafa Raoof  1
Affiliations
Clinical Trial

Safety of pressurized intraperitoneal aerosolized chemotherapy in biliary cancer patients with peritoneal metastases

Daneng Li et al. Future Oncol. 2024.

Abstract

Biliary tract cancers are a rare diagnosis with a rising incidence. Up to 20% of patients have peritoneal metastases, resulting in symptoms of ascites, abdominal pain and potential bowel obstruction. A standard of care systemic treatment comprises gemcitabine, cisplatin and durvalumab (gem/cis/durva). However, the clinical benefit among patients with peritoneal metastases remains unknown. Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) delivers chemotherapy directly to the peritoneal space, which could potentially improve efficacy with minimal systemic toxicity. We describe the design of a Phase I study investigating PIPAC with nab-paclitaxel plus systemic gem/cis/durva among biliary tract cancer patients with peritoneal metastases who have not received prior systemic treatment. The primary end point is safety of PIPAC with nab-paclitaxel in combination with systemic gem/cis/durva.Clinical Trial Registration: NCT05285358 (ClinicalTrials.gov).

Keywords: PIPAC; biliary tract cancer; cholangiocarcinoma; cisplatin; durvalumab; gallbladder cancer; gemcitabine; nab-paclitaxel.

Plain language summary

[Box: see text].

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Conflict of interest statement

D Li has received research funding from AstraZeneca and has received honoraria and advisory/consulting fees from AbbVie, Adagene, AstraZeneca, Coherus, Delcath Systems, Eisai, Exelixis, Genentech, Ipsen, Merck, QED, Servier, Sumitomo Pharma Oncology, TerSera, TransThera Biosciences and TriSalus Life Sciences. C Crook reports no conflicts of interest. V Chung has received research funding from Merck and has served in a consulting or advisory role for Perthera. G Brar reports no conflicts of interest. M Fakih has received research funding from AgenusBio, Amgen, Genentech/imCORE and Verastem and has received honoraria and advisory/consulting fees from AbbVie, Adagene, AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, Entos, GlaxoSmithKline, Guardant Health, Incyte, Janssen, Merck, Mirati Therapeutics, Nouscom, Pfizer, Roche/Genentech, Seattle Genetics, Taiho and Xenthera. A Barzi has received research funding from Bayer and Merck, holds a leadership role at Cardiff Oncology and has received honoraria and advisory/consulting fees from Bayer Technology System, BioTheranostics, Daiichi Sankyo/AstraZeneca, Helsinn Therapeutics/QED Therapeutics and Merrion. L Melstrom reports no conflicts of interest. G Singh holds patents on a device unrelated to the current study. Y Fong holds stock and other ownership interests in Imugene (self) and Pfizer (immediate family member), holds patents/royalties/other intellectual property on viral vectors licensed to Imugene and Merck and has received advisory/consulting fees from Imugene, Medtronic, Sovato Health and Vergent Bioscience. P Frankel holds stock in Geron and serves on an external data and safety monitoring committee for Johnson & Johnson/Janssen. M Raoof has received research funding from Exact Sciences. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Figures

Figure 1.
Figure 1.
Study schema. AE: Adverse event; DLT: Dose-limiting toxicity; IP: Intraperitoneal; IV: Intravenous; PIPAC: Pressurized intraperitoneal aerosolized chemotherapy; Q3W: Every 3 weeks; Q4W: Every 4 weeks.
See this image and copyright information in PMC

References

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