INTERACT Stomach-II

NCT07133490 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-521468-36-00
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peritoneal Metastases From Gastric Cancer

Keywords

Gastric cancer; Peritoneal metastases; Intraperitoneal chemotherapy; Irinotecan

Outcome Measures

Primary Outcomes (1)

• Feasibility of intraperitoneal administration of irinotecan

  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)

  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)

Study Arms (1)

Intraperitoneal chemotherapy arm

EXPERIMENTAL

Patients in this group will receive intraperitoneal irinotecan in addition to standard systemic therapy

Drug: intraperitoneal chemotherapy

Interventions

intraperitoneal chemotherapy DRUG

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

Intraperitoneal chemotherapy arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Catharina Ziekenhuis Eindhoven: collaborator
• Netherlands Cancer Institute - NKI: collaborator

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Pieter C van der Sluis, MD PhD

  Erasmus MC, University Medical Center Rotterdam

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Micha J de Neijs, Bsc

CONTACT

010 70 39640; m.deneijs@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 21, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share