Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer
Trial Parameters
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * Patients with histologically confirmed GC/PM only and/or positive peritoneal cytology, who have completed prior systemic chemotherapy for a minimum of 2 to 4 months duration. * Age ≥18 years. Because no dosing or adverse event data are currently available on the use of HIPEC for GC/PM in patients under 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials. * ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A). * Patients must have adequate organ and marrow function as defined below: * leukocytes ≥3,000/mcL * absolute neutrophil count ≥1,500/mcL * platelets ≥100,000/mcL * total bilirubin ≤ institutional upper limit of normal (ULN) * AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN * creatinine ≤ institutional ULN OR * glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2 (see Appendix B). * Human immunodeficiency