Irinotecan hydrochloride trihydrate for Gastric cancer with peritoneal metastases

Inclusion criteria

• {"criterion_text":"- Histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma"}
• {"criterion_text":"- Pathologically and clinically confirmed diagnosis of macroscopic peritoneal metastases (defined as PCI score ≥ 1)"}
• {"criterion_text":"- WHO-performance score of 0 to 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":"- Distant metastases other than peritoneal metastases or metastatic lymph nodes"}
• {"criterion_text":"- Absence of assurance of compliance with the protocol."}
• {"criterion_text":"- Prior palliative systemic therapy for gastric cancer"}
• {"criterion_text":"- Prior (neo)-adjuvant systemic therapy for gastric cancer within the six months before enrolment in this study"}
• {"criterion_text":"- Severe symptomatic ascites requiring monthly recurrent therapeutic paracentesis"}
• {"criterion_text":"- Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency"}
• {"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":"- adequate 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)"}
• {"criterion_text":"- Pregnant or lactating women"}
• {"criterion_text":"- Concomitant participation in any clinical study that could modify the outcomes relevant to this study"}

Primary endpoints

• {"endpoint_text":"- Feasibility, determined as the percentage of patients completing all cycles of systemic therapy in combination with intraperitoneal irinotecan","definition_or_measurement_approach":"Determined as the percentage of patients completing all cycles of systemic therapy in combination with intraperitoneal irinotecan"}

Secondary endpoints

• {"endpoint_text":"- Overall survivall, calculated from date of PM until death or last follow-up","definition_or_measurement_approach":"Calculated from date of peritoneal metastases until death or last follow-up"}
• {"endpoint_text":"- Safety of the administered treatment, assessed by all treatment-related AEs, all SAEs, percentage of patients discontinuing treatment due to treatment-related AEs","definition_or_measurement_approach":"Assessed by all treatment-related adverse events (AEs), all serious adverse events (SAEs), and percentage of patients discontinuing treatment due to treatment-related AEs"}
• {"endpoint_text":"- Overall respons rate of iriotecan in combination with systemic therapy for patients with PM of GC, assessed by the percentage of patients demonstrating response of the the treatment","definition_or_measurement_approach":"Assessed by the percentage of patients demonstrating response to the treatment"}
• {"endpoint_text":"- Progression-free survival calculated from date of PM until progression or last follow-up","definition_or_measurement_approach":"Calculated from date of peritoneal metastases until progression or last follow-up"}
• {"endpoint_text":"- QoL at baseline, after the first cycle, after the first radiological response evaluation, and after the last cycle, assessed by: EQ-5D-5L,QLQ-C30 and QLQ-STO22.","definition_or_measurement_approach":"Quality of life assessed at specified timepoints using EQ-5D-5L, QLQ-C30 and QLQ-STO22 instruments"}
• {"endpoint_text":"- Healthcare costs and costs due to productivity losses during and after treatment with IP irinotecan in combination with systemic therapy for patients with PM of GC assessed by questionnaires","definition_or_measurement_approach":"Assessed by questionnaires measuring healthcare costs and productivity loss during and after treatment"}

Netherlands

Earliest CTIS Part Ii Submission Date

05-09-2025

Latest Decision Or Authorization Date

15-09-2025

Processing Time Days

10

Number Of Sites

3

Number Of Participants

49

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands