This is a phase II study conducted in three hospitals in the Netherlands (Erasmus MC in Rotterdam, Catharina Hospital in Eindhoven, and the Netherlands Cancer Institute in Amsterdam). A total of 49 patients will take part. The aim is to test whether a new combination treatment is feasible for patients with gastric peritoneal metastases (PM). The treatment includes chemotherapy (intraperitoneal irinotecan and standard systemic therapy such as CAPOX or FOLFOX), and may also include nivolumab or trastuzumab, depending on biomarker results.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Through a peritoneal access port, irinotecan will be administered at the same time as systemic (chemo)therapy
Feasibility of intraperitoneal administration of irinotecan
Percentage of patients who completed all planned cycles of intraperitoneal irinotecan in combination with systemic therapy (6 cycles in the case of CAPOX, 8 cycles in the case of FOLFOX)
Time frame: From enrollment until the completion of all chemotherapy cycles: either 6 cycles of CAPOX (21 days per cycle) or 8 cycles of FOLFOX (14 days per cycle)
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