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Personalized Mini-PDX for Metastatic CRPC

2019年11月25日 更新者:Tianjin Medical University Second Hospital

A Single-center, Open, Real World and Prospective Trial of Personalized Mini Patient-Derived Xenograft (MiniPDX ) Modeling in Adult Patients With Metastatic Castration Resistant Prostate Cancer

The investigators intend to use the Second-generation sequencing(NGS)and MiniPDX drug sensitivity models to guide the treatment decision-making for patients who were resistant to abiraterone, enzalutamide or other new second-generation anti-androgenic drugs. In order to develop precise personalized treatment plans for patients and extent their lifetimes.

研究概览

地位

未知

条件

详细说明

Most patients with metastatic prostate cancer are effective in endocrine therapy at the beginning, but after a median survival of 12 to 18 months, almost all patients develop castration-resistant prostate cancer (CRPC). Since the pathogenesis of CRPC is still unknown, the clinical lack of precise treatment for the cause is a difficult and hot topic in current research and treatment. Mini patient derived xenograft (MiniPDX) is a drug sensitivity test model established by transplanting primary human tumor cells into immunodeficient mice by special methods. This efficient drug sensitivity test can provide sensitivities of single drug or drug combination in order to screen out the optimal individualized regimens for each patient. The investigators intend to use the Second-generation sequencing(NGS)and MiniPDX drug sensitivity models to guide the treatment decision-making for patients who were resistant with abiraterone, enzalutamide or other new second-generation anti-androgenic drugs. This project is to develop precise personalized treatment plans for patients and extent their lifetimes.

研究类型

介入性

注册 (预期的)

15

阶段

  • 不适用

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

    • Tianjin
      • Tianjin、Tianjin、中国、300211
        • 招聘中
        • Tianjin Medical University Second Hospital
        • 接触:
          • Haitao Wang

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 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

男性

描述

Inclusion Criteria:

  1. Patient can provide detailed clinical baseline information including: name, age, gender, pathology, past treatment, etc.;
  2. Male, age ≥ 18 years old;
  3. ECOG score 0~2 points;
  4. Patient must be able to provide tissue samples for the drug sensitive test;
  5. No treatment history with PI3K inhibitors, AKT inhibitors or mTOR inhibitors;
  6. Estimated lifetime is ≥ 3 months;
  7. Histological or cytologically determined prostate adenocarcinoma, excluding neuroendocrine differentiation, signet ring cell carcinoma and small cell carcinoma;
  8. Patient is at a castration level and the testosterone level is lower than <50 ng/dL or 1.7 nmol/L;
  9. Received abiraterone or enzalutamide and other new second-generation anti-androgenic drugs and have disease progression. Disease progression is defined by PCWG3 :The progression of disease in PCWG3 is defined as satisfying one of the following: according to the increase in PSA levels, there must be three consecutive increases in PSA at least one week apart, and the minimum value is greater than or equal to 5.0 ng/ml; disease progression as assessed by RECIST 1.1, considering PSA levels or not; PCWG3 defines bone disease progression, which is bone scan found 2 or more new lesions;
  10. Evidence of distant metastatic disease (such as bone scans and CT/MRI results), imaging data that can be used to assess the condition before and after treatment, or imaging experience provided by three imaging hospitals with experience in three hospitals. Test reports and oncology indicators include PSA values;
  11. The patient can tolerate the primary physician to perform the puncture operation, after receiving the informed consent from the patient and the family members;
  12. The follow-up period must be at least greater than 2 months;
  13. Be able to follow the research and follow-up procedures to provide real and effective information;
  14. The patient or his legal guardian understands the test procedure and content and voluntarily signs the printed informed consent form.

Exclusion Criteria:

  1. Cognitive ability and psychological abnormalities
  2. ECOG score 3-4 points or blood biochemical examination indicates that the patient is not suitable for continuing chemotherapy or chemotherapy has been postponed
  3. Can not provide enough tumor puncture tissue, not enough tumor cells for subsequent experiments;
  4. Patient who is unwilling to receive follow-up treatment after the Mini PDX model drug sensitivity test;
  5. The investigator believes that the subject may not be able to complete the study or may not be able to comply with the requirements of this study (for administrative reasons or other reasons).

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
实验性的:MiniPDX Group
Patients medication plan based on MiniPDX drug sensitivity test.
Mini patient derived xenograft (MiniPDX) is a drug sensitivity test model established by transplanting primary human tumor cells into immunodeficient mice by special methods. This test can provide sensitivities of single drug or drug combination within 7 days to screen out the optimal individualized regimens for each patient.

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
大体时间:12 months
The ratio of number of participants with evidence of a confirmed complete response (CR) or partial response (PR) to all participants is objective response rate (ORR) by using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 to evaluate.
12 months

次要结果测量

结果测量
措施说明
大体时间
PFS
大体时间:12 months
Progression-free survival (PFS) is defined as the time from the date of the first administration of patients medication plan based on MiniPDX drug sensitivity test to the date of the first documentation of disease progression or death due to any cause, whichever comes first, censored at the last date at which the participant was determined to be progression-free.
12 months
OS
大体时间:12 months
Overall survival is defined as time from initiation to death of any cause.
12 months
ADR
大体时间:Up to 30 days of last study treatment.
Adverse Drug Reaction:Adverse events determined according to CTCAE (version 4.03) and attribution to study treatment.
Up to 30 days of last study treatment.
Clinical Consistency
大体时间:Up to 2 months of last study treatment.
Overall clinical consistency(accuracy) as assessed by evaluating Response Evaluation Criteria In Solid Tumors (RECIST) criteria in patient tumor and correlating to tumor regression in Mini-PDX model for same drug treatment.
Up to 2 months of last study treatment.

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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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)

2019年1月28日

初级完成 (预期的)

2020年1月27日

研究完成 (预期的)

2021年1月27日

研究注册日期

首次提交

2018年12月6日

首先提交符合 QC 标准的

2018年12月24日

首次发布 (实际的)

2018年12月26日

研究记录更新

最后更新发布 (实际的)

2019年11月26日

上次提交的符合 QC 标准的更新

2019年11月25日

最后验证

2019年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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MiniPDX Group的临床试验

3
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