| NCT ID | NCT07133490 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Erasmus Medical Center |
| Condition | Peritoneal Metastases From Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 55 participants in total. It began in 2025-10-01 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Pieter C van der Sluis, MD PhD
PRINCIPAL INVESTIGATOR
Erasmus MC, University Medical Center Rotterdam
Frequently Asked Questions
Who can join the NCT07133490 clinical trial?
This trial is open to participants of all sexes, studying Peritoneal Metastases From Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07133490 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07133490 currently recruiting?
Yes, NCT07133490 is actively recruiting participants. Contact the research team at m.deneijs@erasmusmc.nl for enrollment information.
Where is the NCT07133490 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Eindhoven, Netherlands, Rotterdam, Netherlands.
Who is sponsoring the NCT07133490 clinical trial?
NCT07133490 is sponsored by Erasmus Medical Center. The principal investigator is Pieter C van der Sluis, MD PhD at Erasmus MC, University Medical Center Rotterdam. The trial plans to enroll 55 participants.
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