Actively Recruiting
Intraperitoneal Irinotecan Combined With Systemic Therapy for Patients With Gastric Peritoneal Metastases A Phase II, Multicenter Study
Led by Erasmus Medical Center · Updated on 2026-06-01
55
Participants Needed
3
Research Sites
39 weeks
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
C
Catharina Ziekenhuis Eindhoven
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a phase II study in the Netherlands to evaluate a new combination treatment for patients with gastric cancer that has spread to the peritoneum (gastric peritoneal metastases). The study aims to determine if adding intraperitoneal irinotecan chemotherapy to standard systemic treatments is feasible. The study may also include additional drugs, nivolumab or trastuzumab, depending on patients' biomarker results. Patients will receive intraperitoneal irinotecan through a special access port alongside standard systemic chemotherapy such as CAPOX or FOLFOX. The treatment consists of either 6 cycles of CAPOX (each cycle lasting 21 days) or 8 cycles of FOLFOX (each cycle lasting 14 days). This combined approach is being tested at three hospitals to assess its practical use in patients. During the study, patients will be closely monitored from enrollment until they complete all chemotherapy cycles. Researchers will evaluate the feasibility of administering irinotecan directly into the peritoneum alongside systemic therapy. Participants will undergo regular assessments to track treatment adherence and safety. The total involvement duration depends on the chemotherapy regimen chosen, lasting through all treatment cycles.
CONDITIONS
Brief Title
INTERACT Stomach-II
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma
- Pathologically and clinically confirmed diagnosis of macroscopic peritoneal metastases (defined as PCI score 21 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Either 6 cycles of CAPOX (21 days per cycle) or 8 cycles of FOLFOX (14 days per cycle)
Participants receive intraperitoneal irinotecan administered through a peritoneal access port combined with standard systemic chemotherapy.
Multiple visits corresponding to chemotherapy cycles
Trial Site Locations
Total: 3 locations
1
Antoni van Leeuwenhoek
Amsterdam, Netherlands
Actively Recruiting
2
Catharina Hospital
Eindhoven, Netherlands
Actively Recruiting
3
Erasmus MC, University Medical Center Rotterdam
Rotterdam, Netherlands
Actively Recruiting
Research Team
M
Micha J de Neijs, Bsc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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