INTERACT Stomach-II
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: intraperitoneal chemotherapy.
- Who it may be relevant to
- Registry conditions: Peritoneal Metastases From Gastric Cancer. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intraperitoneal Irinotecan Combined With Systemic Therapy for Patients With Gastric Peritoneal Metastases: A Phase II, Multicenter Study
Overview
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.
Interventions
- Drug intraperitoneal chemotherapy
Through a peritoneal access port, irinotecan will be administered at the same time as systemic (chemo)therapy
Primary outcome measures
- Feasibility of intraperitoneal administration of irinotecan [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)]
Eligibility criteria
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 compliance with the protocol
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 3 centers
- Antoni van Leeuwenhoek — Amsterdam
- Catharina Hospital — Eindhoven
- Erasmus MC, University Medical Center Rotterdam — Rotterdam
Identifiers
NCT: NCT07133490 · 2025-521468-36-00 · 2025-521468-36-00