Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer
2021年5月21日 更新者：Tianjin Medical University Cancer Institute and Hospital
A Prospective, Single-center Clinical Study to Explore the Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer
This study is being conducted to explore the efficacy and safety of SHR-1020 combined with albumin-bound paclitaxel in the second-line treatment of advanced pancreatic cancer.
研究概览
详细说明
This trial is a prospective, single-center, single-arm clinical research. Advanced pancreatic cancer is an aggressive disease with extremely low 5-year survival rate. For advanced pancreatic cancer patients who failed with first-line treatment, subsequent treatment options are limited. SHR-1020 combined with albumin-bound paclitaxel could through multiple mechanisms such as block tumor mitosis, inhibit tumor angiogenesis, inhibit interstitial fibrosis to achieve anti-tumor effect.
The safety and efficacy of this study will be assessed through ORR, DCR,PFS, OS , and adverse effects as graded by CTCAE 5.0.
研究类型
介入性
注册 (预期的)
39
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Tianjin
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Tianjin、Tianjin、中国、300000
- 招聘中
- Tianjin Medical University Cancer Institute and Hospital
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接触：
- jihui Hao, MD
- 电话号码：022-23524155
- 邮箱：ec_tjcih@126.com
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接触：
- chuntao Gao, MD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients who were diagnosed as metastatic or locally advanced unresectable pancreatic ductal adenocarcinoma by histopathology or cytology, at least one measurable lesion conforming to RECIST 1.1 criteria.
- Disease progresses or intolerance for first-line standard treatment, including patients who relapsed or metastasized within 6 months of neoadjuvant or adjuvant therapy
- ECOG score 0-2
- Adequate organ and bone marrow function
- The expected survival time is ≥ 12 weeks
- Had normal swallowing function, without dysfunction of gastrointestinal absorption
- Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures
Exclusion Criteria:
- The patient has previously received anti-angiogenic drugs or albumin-bound paclitaxel;
- The first study drug treatment was less than 2 weeks or 5 half-lives (in terms of longer) from the last chemotherapy or 5 half-lives from the last targeted therapy
- Known to be allergic to the active ingredients or excipients in this study.
- Had other active malignant tumors within 5 years before entering the study.
- Subject with cerebral metastasis
- Have a clear history of serious and uncontrolled other disease or mental disorders;
- Other chemotherapy, targeted therapy, hormonotherapy, immunotherapy, radiotherapy or traditional Chinese medicine should be used for anti-tumor therapy
- Other situations that the researcher considers inappropriate to participate in the research.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：SHR-1020 combined with albumin-bound paclitaxel
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SHR-1020 combined with albumin-bound paclitaxel for advanced pancreatic cancer
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
ORR (Objective Response Rate)
大体时间：From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
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Containing the incidence of complete response (CR) and partial response (PR).
Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
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From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
DCR (Disease Control Rate)
大体时间：From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
|
Containing the incidence of complete response (CR), partial response (PR) and stable disease (SD).Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
|
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
|
|
PFS (Progression-Free-Survival)
大体时间：From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months
|
From date of treatment start until the date of progression or the date of death due to any cause.Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
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From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months
|
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6mPFS
大体时间：Up to 6 months
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6-month- Progression-Free-Survival rate.
Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
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Up to 6 months
|
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OS (overall survival)
大体时间：From date of treatment start until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 12 months
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From date of treatment start to any cause death or last follow-up.
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From date of treatment start until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 12 months
|
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Adverse events (per CTCAE v5.0 criteria)
大体时间：Up to 12months
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To evaluate the adverse events of patients with advanced pancreatic cancer after treated with SHR-1020 plus albumin-bound paclitaxel
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Up to 12months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年4月22日
初级完成 (预期的)
2023年7月1日
研究完成 (预期的)
2023年7月1日
研究注册日期
首次提交
2021年3月17日
首先提交符合 QC 标准的
2021年3月22日
首次发布 (实际的)
2021年3月24日
研究记录更新
最后更新发布 (实际的)
2021年5月25日
上次提交的符合 QC 标准的更新
2021年5月21日
最后验证
2020年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
SHR-1020+albumin-bound paclitaxel的临床试验
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Tianjin Medical University Cancer Institute and...尚未招聘