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Intraperitoneal Irinotecan + Systemic Therapy for Gastric Peritoneal Metastases
NCT07133490Phase 2
Key facts
- Status
- Recruiting
- Start
- Oct 2025
- Primary completion
- Oct 2027
- Countries
- 1
- Sponsor
- Erasmus MC
- Modality
- Small Molecules
- Drugs
- irinotecan
- Conditions
- gastric cancer (GC)Peritoneal metastases
01
Overview
Phase 2, open-label, single-arm trial of irinotecan in gastric cancer (GC) and Peritoneal metastases, sponsored by Erasmus MC. Primary endpoint: Feasibility of intraperitoneal administration of irinotecan. Started Oct 2025; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Intraperitoneal chemotherapy arm
Patients receive intraperitoneal irinotecan in addition to standard systemic therapy (CAPOX or FOLFOX, +/- nivolumab or trastuzumab).
03
Who it enrols
Adult patients with histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma with macroscopic peritoneal metastases, WHO PS 0-1, no prior palliative systemic therapy, and adequate organ function.
04
Endpoints
Primary
Feasibility of intraperitoneal administration of irinotecan
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