To assess if PD-L1 expression can be upregulated in peritoneal metastases from gastric cancer after the administration of HIPEC with greater frequency compared to systemic chemotherapy alone
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Laparoscopic HIPEC will be performed at a maximum of two (2) times spaced approximately 6 weeks apart. The dosing of the drugs will be the same during each administration but adjusted if needed based on lab work. The typical dosages are 200mg of Cisplatin
Laparoscopic HIPEC will be performed at a maximum of two (2) times spaced approximately 6 weeks apart. The dosing of the drugs will be the same during each administration but adjusted if needed based on lab work. The typical dosages are 30mg of Mitomycin C.
University of Chicago
Chicago, Illinois, United States
RECRUITINGThe PD-L1 expression can be upregulated after administration of HIPEC with greater frequency
To examine if PD-L1 expression can be upregulated in peritoneal metastases from gastric cancer after the administration of HIPEC with greater frequency compared to systemic chemotherapy alone. PD-L1 expression will be measured quantitatively by combined positive score (CPS), with upregulation defined as an quantitative increase in PD-L1 expression via CPS compared to the previously measured timepoint (baseline CPS of 0).
Time frame: 2 years
The rate of conversion to resectability with repeated interval laparoscopic HIPEC
To examine the rate of conversion to resectability with repeated interval laparoscopic HIPEC as defined by the Phase II trial published by Badgwell et al.
Time frame: 2 years
To quantitatively assess peritoneal cancer index (PCI) change with repeated interval laparoscopic HIPEC.
To quantitatively assess peritoneal cancer index (PCI) change with repeated interval laparoscopic HIPEC.
Time frame: 2 years
Overall Survival Rate
To examine overall survival from diagnosis of metastatic disease. Given the potential for longer survival with repeated interval laparoscopic HIPEC compared to systemic chemotherapy alone, this metric will be assessed. In addition, in (+)PD-L1 patients, survival data in this population undergoing repeated interval laparoscopic HIPEC and systemic PD-1 inhibition is unknown.
Time frame: 2 years
Perioperative morbidity at 30 days
To assess perioperative morbidity at 30 days.
Time frame: 30 days
Perioperative mortality at 30 days
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To assess perioperative mortality at 30 days.
Time frame: 30 days