Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
49
Countries
1
Sites
3
Gastric peritoneal metastases
To evaluate the feasibility of IP irinotecan in combination with systemic therapy for patients with PM of GC.
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
- 29 Sep 2025 → ongoing
- Decision date (initial)
- 2025-09-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Erasmus MC
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Others, Safety
To evaluate the feasibility of IP irinotecan in combination with systemic therapy for patients with PM of GC.
Secondary objectives 6
- To evaluate the efficacy of IP irinotecan in combination with systemic therapy for patients with PM of GC.
- Assessment of the toxicity profile of IP irinotecan in combination with systemic therapy for patients with PM of GC.
- Assessment of the overall response rate (ORR) of IP irinotecan in combination with systemic therapy for patients with PM of GC.
- Assessment of the progression-free survival (PFS) of IP irinotecan in combination with systemic therapy for patients with PM of GC.
- Assessment of the quality of life (QoL) during and after treatment with IP irinotecan in combination with systemic therapy for patients with PM of GC.
- Assessment of 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.
Conditions and MedDRA coding
Gastric peritoneal metastases
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma
- Pathologically and clinically confirmed diagnosis of macroscopic peritoneal metastases (defined as PCI score ≥ 1)
- WHO-performance score of 0 to 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
Exclusion criteria 10
- Distant metastases other than peritoneal metastases or metastatic lymph nodes
- Prior palliative systemic therapy for gastric cancer
- Prior (neo)-adjuvant systemic therapy for gastric cancer within the six months before enrolment in this study
- Severe symptomatic ascites requiring monthly recurrent therapeutic paracentesis
- Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency
- 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
- 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)
- Pregnant or lactating women
- Concomitant participation in any clinical study that could modify the outcomes relevant to this study
- Absence of assurance of compliance with the protocol.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Feasibility, determined as the percentage of patients completing all cycles of systemic therapy in combination with intraperitoneal irinotecan
Secondary endpoints 6
- Overall survivall, calculated from date of PM until death or last follow-up
- Safety of the administered treatment, assessed by all treatment-related AEs, all SAEs, percentage of patients discontinuing treatment due to treatment-related AEs
- 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
- Progression-free survival calculated from date of PM until progression or last follow-up
- 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.
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Irinotecan Accord 20 mg/ml concentraat voor oplossing voor infusie
PRD4362142 · Product
- Active substance
- Irinotecan Hydrochloride Trihydrate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAPERITONEAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XX19 — IRINOTECAN
- Marketing authorisation
- BE 500800
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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
- dr P.C. van der Sluis
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- dr P.C. van der Sluis
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 49 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2025-09-29 | 2025-09-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-521468-36-00 TC | 1.1 |
| Protocol (for publication) | D1_Protocol 2025-521468-36-00 Clean | 3 |
| Recruitment arrangements (for publication) | K_recruitment text v1 | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant participant or partner of a pregnant participant v1 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPc Irinotecan | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis NL | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-26 | Netherlands | Acceptable 2025-09-09
|
2025-09-15 |