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Intraperitoneal Irinotecan Combined With Systemic Therapy for Patients With Gastric Peritoneal Metastases: A Phase II, Multicenter Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Antoni van Leeuwenhoek
RECRUITING
Amsterdam
Catharina Hospital
RECRUITING
Eindhoven
Erasmus MC, University Medical Center Rotterdam
RECRUITING
Rotterdam
Contact Information
Primary
Micha J de Neijs, Bsc
m.deneijs@erasmusmc.nl
010 70 39640
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 55
Treatments
Experimental: Intraperitoneal chemotherapy arm
Patients in this group will receive intraperitoneal irinotecan in addition to standard systemic therapy
Related Therapeutic Areas
Stomach Cancer
Sponsors
Collaborators: The Netherlands Cancer Institute, Catharina Ziekenhuis Eindhoven
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov

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