INTERACT Stomach-II
Recruiting now · Phase 2
Conditions studied: Peritoneal Metastases From Gastric Cancer
In brief
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.
Key facts
- Study ID
- NCT07133490
- Run by
- Erasmus Medical Center
- People needed
- 55
- Starts
- 2025-10-01
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2026-06-01
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 compliance with the protocol
Where it is running
- Antoni van Leeuwenhoek — Amsterdam, Netherlands (enrolling)
- Catharina Hospital — Eindhoven, Netherlands (enrolling)
- Erasmus MC, University Medical Center Rotterdam — Rotterdam, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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