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临床试验/NCT02979795
NCT02979795Unknown不适用

Translational Research in Identifying Molecular Mechanisms for Rectal Cancer Metastasis

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Tumor regression rate

研究概览

简要总结

Rectal cancer, comprised of 30% of overall colorectal cancer cohort, is one of the leading cancers of Taiwan. In patients with advanced disease, the standard of care is concurrent chemoradiotherapy (CCRT) before surgery. After CCRT, the abscopal effect, a phenomenon that localized radiation not only destroys local tumor but also inhibits the growth of tumor at the remote site, has been observed. This effect is believed to be associated with tumor immune response. In addition, other immune checkpoint molecules, such as Programmed cell death-1(PD-1), Programmed cell death ligand-1 (PD-L1), and Cytotoxic T-Lymphocyte Associated Protein 4 (CTLA-4), have been reported associated with therapeutic outcome. However, after CCRT, more than 50% of patients were still either having persistent disease or developed distant metastasis. To improve therapeutic outcome of patients with rectal cancer, this project, thus, aims at exploring the evolution of factors that may affect the abscopal effect and immune checkpoint functions in tissues and in blood before and after CCRT.

详细描述

For most patients, preoperative chemoradiotherapy results in clinically tumor regression, but the degree of response varies among patients. There are approximately 40-60% of LARC patients treated with CCRT achieve some degree of pathologic response. However, there is yet an effective method before the commencement of CCRT that can predict how patients will respond to CCRT and can subsequently render better survival. Identify patents who will benefit most from CCRT is crucial not only in lowering treatment-related morbidity and sustaining local control but also to improve survival rate in LARC.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Rectal cancer patients in China Medical University Hospital (Age limit: 20 yrs and older)

排除标准

  • Pregnancy, Disabilities

结局指标

主要结局

Tumor regression rate

时间窗: within 8 weeks after completion of chemoradiotherapy

complete tumor regression rate(TRG) with tumor regression graded at at surgical resection at 8 weeks after completion of chemoradiotherapy

次要结局

  • Disease free survival(5 year)
  • Overall survival(5 year)
  • Local recurrence(5 year)
  • Distant metastasis(5 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kun-San Clifford Chao

Cancer center

China Medical University Hospital

研究点 (1)

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