Peri-operative intraperitoneal irinotecan and systemic FLOT in the curative treatment of gastric cancer and gastroesophageal junction cancer: a phase I study

Condition studied

Gastric cancer

Investigational medicinal product(s)

Eligibility

Primary endpoint

The MTD will be established using a 3+3 dose escalation design in which the amount of DLTs will determine the MTD

Endpoint detail

Safety of the administered treatment, assessed by: - All treatment-related adverse events (AEs) according to CTCAE; - All serious adverse events (SAEs); - All postoperative complications, Percentage of patients discontinuing treatment due to treatment-related adverse events • Percentage of patients getting to resection after preoperative chemotherapy, Assessed by the pharmacokinetic parameters and peritoneum/plasma ratio during the second treatment cycle, Assessed by comparing UGT1A1 genotype and pharmacokinetic parameters in the peritoneal cavity