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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04059562 | Trifluridine/Tipiracil in Combination With Irinotecan as a Second Line Therapy in Patients With Cholangiocarcinoma | PHASE2 | COMPLETED | 28 | — | — | Oct 28, 2021 | Jan 8, 2024 | Mar 27, 2024 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | Combination of Lonsurf® and Irinotecan |
| Name | Type | Description |
|---|---|---|
| Combination of Lonsurf® and Irinotecan | COMBINATION_PRODUCT | Trifluridine/Tipiracil (Lonsurf®) and Irinotecan * Trifluridine/Tipiracil will be administered at a dose of 25 mg/m2 / dose twice daily on days 1-5 followed by a 9-days recovery period from day 6 trough day 14 of each 14-days treatment cycle. * Irinotecan will be administered at the same time as Trifluridine/Tipiracil (Lonsurf®) on day 1 of each cycle at a dose of 180 mg/m2 / dose. |
Inclusion Criteria: 1. Written informed consent incl. participation in translational research and any locally-required authorization (EU Data Privacy Directive in the EU) prior to performing any protocol-related procedures, including screening evaluations 2. Age ≥ 18 years at time of study entry 3....