INTERACT Stomach-II

Not Applicable

Not yet recruiting

• Conditions: Peritoneal Metastases From Gastric Cancer
• Interventions: Drug: intraperitoneal chemotherapy

• Registration Number: NCT07133490
• Lead Sponsor: Erasmus Medical Center

Brief 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 49 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-06
• Study First Submitted QC: 2025-08-18
• Last Update Submitted: 2025-08-18
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21
• Study Start: 2025-10-01
• Primary Completion: 2027-10-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraperitoneal chemotherapy arm	intraperitoneal chemotherapy	Patients in this group will receive intraperitoneal irinotecan in addition to standard systemic therapy

Primary Outcome Measures

Name	Time	Method
Feasibility of intraperitoneal administration of irinotecan	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)