INTERACT Stomach-II
Key facts
- Where
- Amsterdam, Eindhoven, and Rotterdam, NetherlandsSee the 3 sites
- Phase
- Phase 2
Where in Netherlands
- Antoni van LeeuwenhoekAmsterdam, NetherlandsTaking people
- Catharina hospitalEindhoven, NetherlandsTaking people
- Erasmus MC, University Medical Center RotterdamRotterdam, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Medical Center
- Trial code
- NCT07133490EU 2025-521468-36-00
- Record updated
- 21 October 2026
- Original description
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.Read full original descriptionShow less
Intraperitoneal Irinotecan Combined With Systemic Therapy for Patients With Gastric Peritoneal Metastases: A Phase II, Multicenter Study
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.
Inclusion: 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: Prior palliative systemic therapy for gastric cancer; Prior (neo)-adjuvant systemic therapy for gastric cancer within the six months before enrolment in this study; 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; Concomitant participation in any clinical study that could modify the outcomes relevant to this study; 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); Distant metastases other than peritoneal metastases or metastatic lymph nodes; Severe symptomatic ascites requiring monthly recurrent therapeutic paracentesis; Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency; Pregnant or lactating women; Absence of assurance of compliance with the protocol.