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
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •second malignancy
- •Pregnancy and lactation
- •no prior liver radiation
- •liver metastasis must be resectable
结局指标
主要结局
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
时间窗: 2 years
次要结局
- To determine local control and recurrence patterns of colorectal liver metastases in a CT(2 years)
- To determine the progression-free survival in patients treated with low dose photon beam radiation therapy(2 years)
- • To determine the surgical morbidity in patients undergoing liver resection who received this protocol treatment(2 years)
- • To determine 30-day post-operative mortality after liver resection in patients who received this protocol treatment(2 years)
- • To determine the T-cell activity in the resected liver tissue(2 years)
- • To determine quality of life according to the EORTC QoL questionnaire after 6 months.(6 months)
- To determine the number of regulatory T-cells in the resected liver tissue(2 years)
- To determine the frequencies of tumor-reactive T-cells in the blood and bone marrow of the patients(2 years)
- To determine quality of life according to the EORTC QoL questionnaire after 12 months.(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(2 years)