Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients
第3相
完了
NCT04737187
| 対象疾患 | Refractory Metastatic Colorectal Cancer |
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| 相 | 第3相 |
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| スポンサー | Taiho Oncology, Inc. |
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| ステータス | 完了 |
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| 参加者数 | 492 名 |
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| 介入（薬剤） | Trifluridine/Tipiracil, Bevacizumab |
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| 開始日 | 2020年11月25日 |
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| 完了日 | 2022年7月19日 |
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| 結果公開日 | 2023年12月26日 |
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概要
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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