INTERACT Stomach-II
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorErasmus Medical Center
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- intraperitoneal chemotherapy
Treatment groups
55 Participants
are divided into 1 treatment groupSponsors and collaborators
Erasmus Medical Center
Lead sponsor
Catharina Ziekenhuis Eindhoven
Collaborator
The Netherlands Cancer Institute
Collaborator
Source ClinicalTrials.gov