IRINOTECAN HYDROCHLORIDE TRIHYDRATE for Gastric cancer | Gastroesophageal junction cancer

Inclusion criteria

• {"criterion_text":"- Histologically confirmed GC or GEJ adenocarcinoma planned to (sub)total gastrectomy in combination with perioperative systemic FLOT chemotherapy"}
• {"criterion_text":"- WHO-performance score 0 -1 with a life expectancy greater than or equal to three months"}
• {"criterion_text":"- Aged 18 years or older"}
• {"criterion_text":"- Written informed consent according to the ICH-GCP and national/local regulations."}

Exclusion criteria

• {"criterion_text":"- 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;"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Pregnant or lactating women"}
• {"criterion_text":"- Concomitant participation in any clinical study that could modify the outcomes relevant to this study"}
• {"criterion_text":"- Unwillingness or inability to comply with the study protocol."}

Primary endpoints

• {"endpoint_text":"- The MTD will be established using a 3+3 dose escalation design in which the amount of DLTs will determine the MTD","definition_or_measurement_approach":"Established using a 3+3 dose escalation design where the number of dose-limiting toxicities (DLTs) determines the maximum tolerated dose (MTD)."}

Secondary endpoints

• {"endpoint_text":"- Safety of the administered treatment, assessed by: - All treatment-related adverse events (AEs) according to CTCAE; - All serious adverse events (SAEs); - All postoperative complications","definition_or_measurement_approach":"Assessed by all treatment-related adverse events (AEs) according to CTCAE, all serious adverse events (SAEs), and all postoperative complications."}
• {"endpoint_text":"- Percentage of patients discontinuing treatment due to treatment-related adverse events • Percentage of patients getting to resection after preoperative chemotherapy","definition_or_measurement_approach":"Measured as percentage of patients discontinuing treatment due to treatment-related AEs and percentage of patients reaching surgical resection after preoperative chemotherapy."}
• {"endpoint_text":"- Assessed by the pharmacokinetic parameters and peritoneum/plasma ratio during the second treatment cycle","definition_or_measurement_approach":"Pharmacokinetic parameters and peritoneum-to-plasma concentration ratio measured during the second treatment cycle."}
• {"endpoint_text":"- Assessed by comparing UGT1A1 genotype and pharmacokinetic parameters in the peritoneal cavity","definition_or_measurement_approach":"Comparison of UGT1A1 genotype with pharmacokinetic parameters of irinotecan in the peritoneal cavity."}

Netherlands

Earliest CTIS Part Ii Submission Date

04-03-2026

Latest Decision Or Authorization Date

16-03-2026

Processing Time Days

12

Number Of Sites

2

Number Of Participants

18

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands