Combination intraperitoneal and systemic therapy for gastric cancer with peritoneal metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter Phase II interventional study in the Netherlands aiming to assess feasibility of a new combination therapy for gastric cancer with peritoneal metastases. Fifty-five patients will receive intraperitoneal irinotecan along with standard systemic chemotherapy (CAPOX or FOLFOX), with potential addition of nivolumab or trastuzumab based on tumor biomarkers. Eligibility includes histologically confirmed gastric/GEJ adenocarcinoma with visible peritoneal metastases (PCI ≥ 1), good performance status, and life expectancy of at least three months. Exclusion criteria include non-peritoneal metastases, recent systemic therapy, and contraindications to systemic chemotherapy. The study is conducted at Erasmus MC, Catharina Hospital, and Netherlands Cancer Institute, led by Erasmus MC with collaborators at partner centers.

Why it matters

Who can join: the full rules

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

Where it's running

• Antoni van Leeuwenhoek
  Amsterdam, Netherlands Recruiting
• Catharina Hospital
  Eindhoven, Netherlands Recruiting
• Erasmus MC, University Medical Center Rotterdam
  Rotterdam, Netherlands Recruiting

Study contacts

• Principal investigator: Pieter C van der Sluis, MD PhD — Erasmus MC, University Medical Center Rotterdam
• Study coordinator: Micha J de Neijs, Bsc
• Email: m.deneijs@erasmusmc.nl
• Phone: 010 70 39640

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.