Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Authorised, recruitment pending
Participants planned
39
Countries
1
Sites
3
Colorectal liver metastases
Key facts
- Sponsor
- Leids Universitair Medisch Centrum (LUMC)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-07-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Colorectal liver metastases
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Leids Universitair Medisch Centrum (LUMC)
- Sponsor organisation
- Leids Universitair Medisch Centrum (LUMC)
- Address
- Albinusdreef 2
- City
- Leiden
- Postcode
- 2333 ZA
- Country
- Netherlands
Scientific contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- Saskia Dolfing
Public contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- Saskia Dolfing
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 39 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-23 | Netherlands | Acceptable 2026-07-03
|
2026-07-03 |