A Prospective Cohort Study of Patients With Hepatobiliary Cancer Treated With Immune Checkpoint Inhibitors
赞助:
Asan Medical Center
合作者:
信息的提供 (责任方):
Changhoon Yoo，Asan Medical Center
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 3, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | July 1, 2018 | ||
| 预计主要完成日期 | July 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Objective response rate[ Time Frame: 6 months ] Proportion of complete response and partial response according to the Response Evaluation Criteria in Solid Tumors version 1.1 |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | A Prospective Cohort Study of Patients With Hepatobiliary Cancer Treated With Immune Checkpoint Inhibitors | ||
| 正式标题 ICMJE | A Prospective Cohort Study of Patients With Hepatobiliary Cancer Treated With Immune Checkpoint Inhibitors | ||
| 简要概况 | Although immune checkpoint inhibitors including nivolumab and pembrolizumab are now available for the management of hepatobiliary cancers in Korea, there is a lack of data for the efficacy and safety of these agents in the real-world setting. This study aims to prospectively evaluate the efficacy of safety of nivolumab and pembrolizumab against advanced hepatocellular carcinoma and biliary tract cancer. |
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| 详细说明 | Nivolumab 3 mg/kg intravenous every 2 weeks has been recently approved by US FDA for the management of patients with sorafenib-failed advanced HCC based on the promising data of Checkmate-040 phase I/II study. Although there is a lack of prospective data for pembrolizumab in biliary tract cancer except for small phase 1 trial, pembrolizumab is now available for use in Korea for the management of advanced biliary tract cancer. Because the approval of these agents was based on the small sample size, further prospective evaluation of nivolumab or pembrolizumab in patients with hepatobiliary cancer is needed. | ||
| 研究类型 ICMJE | Observational [Patient Registry] | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational [Patient Registry] 盲法描述: 主要目的: |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
100 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | July 2021 | ||
| 预计主要完成日期 | July 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer) or hepatocellular carcinoma - Planned immune checkpoint inhibitors including nivolumab or pembrolizumab - Written informed consent Exclusion Criteria: - Not available for the treatment with immune checkpoint inhibitors | ||
| 性别 |
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| 年龄 | 最小年龄：19 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Korea, Republic of | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Changhoon Yoo，Asan Medical Center | ||
| 研究赞助商 ICMJE | Asan Medical Center | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Asan Medical Center | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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