INTERACT Stomach-II

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.

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Key information

Conditions

Peritoneal Metastases From Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Antoni van Leeuwenhoek, Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intraperitoneal chemotherapy

Drug

Through a peritoneal access port, irinotecan will be administered at the same time as systemic (chemo)therapy

Primary outcomes

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)

Percentage of patients who completed all planned cycles of intraperitoneal irinotecan in combination with systemic therapy (6 cycles in the case of CAPOX, 8 cycles in the case of FOLFOX)

Study contacts

Contact information is provided by the study sponsor or research team.

Micha J de Neijs, Bsc

CONTACT

[email protected]

010 70 39640

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

Catharina Ziekenhuis Eindhoven
The Netherlands Cancer Institute

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Aug 21, 2025
Registry last updated: Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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