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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

30 Mar 2026 → ongoing

Decision date (initial)

2026-03-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

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

Secondary objectives 4

1. To assess the toxicity profile of IP irinotecan combined with systemic FLOT
2. To assess the feasibility of perioperative IP administration of irinotecan combined with systemic FLOT and surgery
3. Assessment of the pharmacokinetic profile of IP administered irinotecan and the systemic therapy in the intraperitoneal cavit
4. Assessment of the impact of UGT1A1 genotype on the pharmacokinetics of irinotecan

Conditions and MedDRA coding

Gastric cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

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

Exclusion criteria 5

1. 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;
2. 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)
3. Pregnant or lactating women
4. Concomitant participation in any clinical study that could modify the outcomes relevant to this study
5. Unwillingness or inability to comply with the study protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 4

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Sponsor organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Address

Dr. Molewaterplein 40

City

Rotterdam

Postcode

3015 GD

Country

Netherlands

Scientific contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Bianca Mostert

Public contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Bianca Mostert

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications