Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Low Dose Radiation in Colorectal Liver Metastases
Randomised Controlled Phase I/II Trail to Evaluate the Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Low Dose Radiation Therapy in Resectable Colorectal Liver Metastases Patients
The efficiency of T cell based immunotherapies is affected by the insufficient migration and activity of tumor specific effector T cells in the tumor. Aim of this phase I/II clinical trial is to evaluate whether a neoadjuvant, low dose radiotherapy can improve T cell connected anti tumor immune response in colorectal liver metastases.
The primary endpoint is the number of tumor infiltrating T cells. Furthermore the T cell activity in situ, the number of regulatory T cells and the frequency of tumor reactive T cells in the blood and bone marrow will be examined.
研究概览
研究类型
注册 (预期的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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-
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Heidelberg、德国、69120
- 招聘中
- University of Heidelberg
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接触：
- Juergen Weitz
- 电话号码：+49 6221 56 6250
- 邮箱：juergen.weitz@med.uni-heidelberg.de
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接触：
- Christoph Reissfelder
- 电话号码：+49 6221 56 6250
- 邮箱：christoph.reissfelder@med.uni-heidelberg.de
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrolment in the trial)
- Age ≥ 50 years
- Radiological urgently suspected colorectal liver metastasis
Exclusion Criteria:
- second malignancy
- Pregnancy and lactation
- no prior liver radiation
- liver metastasis must be resectable
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 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 |
|---|---|
|
有源比较器：Radiation 0,5Gy
Radiation: one time Radiation with an intensity of 0.5 Gy Group A Beginning on a weekday 48 hours before surgery |
Radiation: one time Radiation with an intensity of 0.5 Gy Group A 2.0 Gy Group B 5 Gy Group C Beginning on a weekday 48 hours before surgery |
|
有源比较器：No radiation
Control group with 0Gy radiation
|
Control group with 0Gy
|
|
有源比较器：Radiation 2Gy
Radiation: one time Radiation with an intensity of 2.0 Gy Group B Beginning on a weekday 48 hours before surgery |
Radiation: one time Radiation with an intensity of 0.5 Gy Group A 2.0 Gy Group B 5 Gy Group C Beginning on a weekday 48 hours before surgery |
|
有源比较器：Radiation 5Gy
Radiation: one time Radiation with an intensity of 5 Gy Group C Beginning on a weekday 48 hours before surgery |
Radiation: one time Radiation with an intensity of 0.5 Gy Group A 2.0 Gy Group B 5 Gy Group C Beginning on a weekday 48 hours before surgery |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumor activity
大体时间：2 years
|
2 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
To determine local control and recurrence patterns of colorectal liver metastases in a CT
大体时间：2 years
|
2 years
|
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To determine the progression-free survival in patients treated with low dose photon beam radiation therapy
大体时间：2 years
|
2 years
|
|
• To determine the surgical morbidity in patients undergoing liver resection who received this protocol treatment
大体时间：2 years
|
2 years
|
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• To determine 30-day post-operative mortality after liver resection in patients who received this protocol treatment
大体时间：2 years
|
2 years
|
|
• To determine the T-cell activity in the resected liver tissue
大体时间：2 years
|
2 years
|
|
• To determine quality of life according to the EORTC QoL questionnaire after 6 months.
大体时间：6 months
|
6 months
|
|
To determine the number of regulatory T-cells in the resected liver tissue
大体时间：2 years
|
2 years
|
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To determine the frequencies of tumor-reactive T-cells in the blood and bone marrow of the patients
大体时间：2 years
|
2 years
|
|
To determine quality of life according to the EORTC QoL questionnaire after 12 months.
大体时间：1 year
|
1 year
|
|
To determine the number of patients with adverse events as a measure of safety and tolerability according to CTCAE, Version 4.0 criteria
大体时间：2 years
|
2 years
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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