Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Oxaliplatin In Patients With Peritoneal Carcinomatosis
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
PIPAC is a procedure that involves the administration of intraperitoneal chemotherapy using
an innovative concept that enhances the efficacy by taking advantage of the physical
properties of gas and pressure. The chemotherapy drugs will be delivered in aerosolised form.
This results in a superior distribution and depth of penetration of the drug.
This research study serves to determine the safety profile and tolerability of PIPAC with
oxaliplatin. It may offer a novel and effective option of treatment for patients with
peritoneal carcinomatosis, who, at present have limited options involving the use of systemic
chemotherapy and who suffer from poor life expectancy and poor quality of life.
To date, most trials have used PIPAC cisplatin with doxorubicin, or oxaliplatin alone, and
more studies are on-going globally.
Intravenous (IV) nivolumab has been approved for the treatment of progressive gastric cancer
after conventional chemotherapy. PIPAC in combination with nivolumab may have the potential
to improve immune activation and response to immune checkpoint inhibition for patients with
peritoneal disease.
Hence we propose an amendment to our trial protocol for the addition of a second cohort
(Cohort 2) to investigate the safety and tolerability of the combination of PIPAC oxaliplatin
and IV nivolumab.