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 55 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.
Who can participate
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma
* Pathologically and clinically confirmed diagnosis of macroscopic peritoneal metastases (defined as PCI score ≥ 1)
* WHO-performance score of 0 to 1 with a life expectancy greater than or equal to three months
* Aged 18 years or older
* Written informed consent according to the ICH-GCP and national/local regulations
Exclusion Criteria:
* Distant metastases other than peritoneal metastases or metastatic lymph nodes
* Prior palliative systemic therapy for gastric cancer
* Prior (neo)-adjuvant systemic therapy for gastric cancer within the six months before enrolment in this study
* Severe symptomatic ascites requiring monthly recurrent therapeutic paracentesis
* Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency
* Any contra-indication for the (planned) systemic chemotherapy (e.g. active infection, serious concomitant disease, severe allergy, persistent neurologic toxicity after (neo-)adjuvant oxaliplatin based systemic therapy), as determined by the treating medical oncologist
* Inadequate organ functions (defined as a hemoglobin \<5.0 mmol/l, an absolute neutrophil count \<1.5 x 109/l, platelet count \<100 x 109/l, creatinine clearance \<30 ml/min, bilirubin \>2x ULN and liver transaminases \>2.5x ULN)
* Pregnant or lactating women
* Concomitant participation in any clinical study that could modify the outcomes relevant to this study
* Absence of assurance of…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of intraperitoneal administration of irinotecan
Timeframe: 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)