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A Phase I, Open-label, Dose-escalating Study of the Safety or Percutaneous Intra-tumoral Injection of TG4023 (MVA-FCU1) Combined With Systemic Administration of 5-fluorocytosine in Patients With Primary or Secondary Hepatic Tumors.
This trial is a phase I, open-label, dose-escalating study of the safety or percutaneous intra-tumoral injection of TG4023 (MVA-FCU1) combined with systemic administration of 5-fluorocytosine in patients with primary or secondary hepatic tumors.
Details
| Lead sponsor | Transgene |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 16 |
| Start date | 2009-09 |
| Completion | 2011-09 |
Conditions
- Hepatocellular Carcinoma
Interventions
- MVA-FCU1, flucytosine
Primary outcomes
- Maximal tolerated dose — 6 months
Countries
France