Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03719924 | Nal-iri/lv5-fu Versus Paclitaxel as Second Line Therapy in Patients With Metastatic Oesophageal Squamous Cell Carcinoma | PHASE2 | COMPLETED | 106 | — | — | Mar 7, 2019 | Sep 29, 2024 | Jan 8, 2025 | 9 | France |
The principal objective is to evaluate survival at 9 months in patients presenting with metastatic oesophageal squamous cell carcinoma (OSC) treated with Nal-IRI/LV5-FU or with paclitaxel.
| Arm | Type | Description |
|---|---|---|
| arm A: ONIVYDE | EXPERIMENTAL | ONIVYDE ONIVYDE will be administered first, followed by folinic acid or L-folinic acid and then 5-FU at D1 and D14 ONIVYDE: 70 mg/m² intravenous over 90 minutes Folinic acid: 400 mg/m² intravenous over 30 minutes or L-folinic acid (racemic form L) 200 mg/m² over 30 minutes 5-FU: 2400 mg/m² over 46 hours |
| Arm B: TAXOL | ACTIVE_COMPARATOR | TAXOL Premedication consists of corticosteroids, H1 antihistamines and H2 antagonists during 30 minutes at time 1 hour before chemotherapy One cycle every 28 days (D1=D28) 80 mg/m2 IV over 60 minutes at D1, D8 and D15 |
| Name | Type | Description |
|---|---|---|
| Onivyde | DRUG | onivyde will be administered first, followed by folinic acid or L-folinic acid and then 5-FU at D1 and D14. |
| Paclitaxel | DRUG | Paclitaxel : 80 mg/m2 IV during 60 minutes at D1, D8 and D15 |
Inclusion Criteria: * Histologically proven metastatic oesophageal squamous cell carcinoma * Patient in failure with 1st-line treatment with oxaliplatin or cisplatin. Patients presenting with resectable disease treated with surgery or neoadjuvant or adjuvant chemotherapy with oxaliplatin or cisplat...