Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
40
Countries
1
Sites
4
Hepatocellular carcinoma
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nantes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Stomatognathic Diseases [C07]
- Trial duration
- 23 Sep 2025 → ongoing
- Decision date (initial)
- 2025-05-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Hepatocellular carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10049010 | Carcinoma hepatocellular | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nantes
- Sponsor organisation
- Centre Hospitalier Universitaire De Nantes
- Address
- 5 Allee De L Ile Gloriette, Cs 69301 Cs 69301
- City
- Nantes Cedex 1
- Postcode
- 44093
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Dr Clément BAILLY
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Dr Clément BAILLY
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 40 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Nantes
Institut des Maladies de l’Appareil Digestif, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
Hopital Beaujon
Nuclear Medecine, 100 Boulevard Du General Leclerc, 92110, Clichy
Hopital Beaujon
Gastro-entérologie et hépatologie, 100 Boulevard Du General Leclerc, 92110, Clichy
Centre Hospitalier Universitaire De Nantes
Nuclear Medecine, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
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 |
|---|---|---|---|---|---|
| France | 2025-09-23 | 2025-09-23 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-11 | France | Acceptable 2025-04-25
|
2025-05-06 |