Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients
Phase 3
Completed
NCT04737187
| Condition | Refractory Metastatic Colorectal Cancer |
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| Phase | Phase 3 |
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| Sponsor | Taiho Oncology, Inc. |
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| Status | Completed |
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| Enrollment | 492 participants |
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| Interventions | Trifluridine/Tipiracil, Bevacizumab |
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| Start date | Nov 25, 2020 |
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| Completion date | Jul 19, 2022 |
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| Results posted | Dec 26, 2023 |
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Summary
This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.
Overall Survival (OS)
From date of randomization to the death due to any cause or cut-off date, whichever comes first (maximum duration: up to 20 months) · months
| Trifluridine/Tipiracil + Bevacizumab | 10.78 months |
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| Trifluridine/Tipiracil | 7.46 months |
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| p-value | < 0.001 |
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| Hazard Ratio (HR) | 0.61 (95% CI 0.49–0.77) |
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Survival Probability at 6 Months
From date of randomization until 6 months post treatment · probability of participants
| Trifluridine/Tipiracil + Bevacizumab | 0.77 probability of participants |
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| Trifluridine/Tipiracil | 0.61 probability of participants |
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Survival Probability at 12 Months
From date of randomization until 12 months post treatment · probability of participants
| Trifluridine/Tipiracil + Bevacizumab | 0.43 probability of participants |
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| Trifluridine/Tipiracil | 0.30 probability of participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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