A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW).
3期
进行中(已停止招募)
NCT03653507
| 适应症 | Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction Adenocarcinoma |
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| 分期 | 3期 |
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| 申办方 | Astellas Pharma Global Development, Inc. |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 507 人 |
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| 干预(药物) | zolbetuximab, oxaliplatin, capecitabine |
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| 开始日期 | 2018年11月28日 |
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| 完成日期 | 2022年10月25日 |
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| 结果公布日 | 2025年1月27日 |
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摘要
Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called GEJ cancer. Most people with this type of cancer have a protein called Claudin 18.2 in their tumor. Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. There is an unmet medical need to treat people with advanced stomach cancer or GEJ cancer. This study will give more information about how well zolbetuximab works when given with chemotherapy in adults with advanced stomach cancer or GEJ cancer. In this study, adults with advanced stomach cancer or GEJ cancer will either be given zolbetuximab with chemotherapy or a placebo with chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it. Zolbetuximab with chemotherapy has already been approved to treat stomach cancer and GEJ cancer in some countries. This study is being done in countries where zolbetuximab has not yet been approved for use. If zolbetuximab becomes approved for use in those countries taking part in this study, the people taking part in those countries will l
Progression Free Survival (PFS)
From the date of randomization until 61 months and 12 days · Months
| CAPOX+ Zolbetuximab | 8.21 Months |
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| CAPOX+ Placebo | 6.80 Months |
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| p-value | 0.0005 |
| Hazard Ratio (HR) | 0.689 (95% CI 0.552–0.860) |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。