Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
第3相
実施中(募集終了)
NCT02912559
| 対象疾患 | Colon Adenocarcinoma, DNA Repair Disorder, Lynch Syndrome, Stage III Colon Cancer AJCC v8 |
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| 相 | 第3相 |
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| スポンサー | National Cancer Institute (NCI) |
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| ステータス | 実施中(募集終了) |
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| 参加者数 | 712 名 |
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| 介入(薬剤) | Atezolizumab, Biospecimen Collection, Computed Tomography, Fluorouracil, Leucovorin Calcium |
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| 開始日 | 2017年10月16日 |
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| 完了日 | 2025年2月4日 |
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| 結果公開日 | 2026年4月14日 |
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概要
This phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair (dMMR). Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better than combination chemotherapy alone in treating patients with dMMR colon cancer.
Disease Free Survival (DFS)
3 years · percentage of participants
| Arm I (Combination Chemotherapy, Atezolizumab) | 86.3 percentage of participants |
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| Arm II (Combination Chemotherapy) | 76.2 percentage of participants |
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| p-value | 0.0002 |
| Hazard Ratio (HR) | 0.50 (95% CI 0.35–0.73) |
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