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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03044587 | Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Biliary-tract Cancer | PHASE2 | COMPLETED | 93 | — | — | Jan 24, 2018 | Jan 31, 2025 | Oct 1, 2025 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| Arm NaI-IRI + 5-FU + Leucovorin (Arm A) | EXPERIMENTAL | Nal-IRI \[Irinotecan liposome\], 5-FU \[5-Fluorouracil\], Leucovorin Cycle q2w |
| Arm Cisplatin + Gemcitabine (Arm B, standard of care) | OTHER | Cisplatin, Gemcitabine Cycle q3w |
| Name | Type | Description |
|---|---|---|
| Arm NaI-IRI + 5-FU + Leucovorin (Arm A) | DRUG | Nal-IRI (80 mg/m2 as a 1.5 hour infusion), 5-FU (2400 mg/m2 as 46 hour infusion) and Leucovorin (400 mg/m2 as 0.5 hour infusion) Cycle q2w |
| Arm Cisplatin + Gemcitabine (Arm B) | DRUG | Cisplatin (25 mg/m2 as 1 hour infusion on D1, D8) and Gemcitabine (1000 mg/m2 as 0.5 hour infusion on D1, D8) Cycle q3w |
Inclusion Criteria: 1. Written informed consent incl. participation in translational research and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations 2. Age ≥ 18 years...