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Peri-operative intraperitoneal irinotecan and systemic FLOT in the curative treatment of gastric cancer and gastroesophageal junction cancer: a phase I study
EU CTIS ID: 2025-522864-34-00
What this study is testing
To determine the MTD and recommended phase II dose of perioperative CBIP irinotecan combined with systemic FLOT in gastric cancer or gastroesophageal junction cancer patients undergoing gastrectomy
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically confirmed GC or GEJ adenocarcinoma planned to (sub)total gastrectomy in combination with perioperative systemic FLOT chemotherapy
- WHO-performance score 0 -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 likely can't join if
- 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 (before transfusion), 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
- Unwillingness or inability to comply with the study protocol.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.