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临床试验/NCT04051450
NCT04051450Unknown不适用

Immune Checkpoints in Colorectal Cancer

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
68
试验地点
1
主要终点
Generation of candidate biomarkers PD-L1/PD1/GEP by laboratory assay qPCR for prognostication.

研究概览

简要总结

Colorectal cancer (CRC) ranked the first in cancer incidence in Hong Kong and it is frequently lethal with heterogeneous drug responses and survival outcomes. Immune-based approaches targeting to enhance tumor-specific responses have been actively under investigation as therapeutic strategies. Currently, PD1 and PD-L1 blockade has shown promising results in clinical trials especially in colorectal cancer patients with microsatellite instability. This study aims to examine the role of PD-L1/PD1 in immune cell-mediated cytotoxicity in colorectal cancer patients.

详细描述

Aim: To examine the role of PD-L1/PD1 in immune cell-mediated cytotoxicity in colorectal cancer patients.

Objectives: 1. Comprehensive investigation of PD-L1/PD1 in colorectal cancer in association with chemotherapy responses and immune activities; 2. Examine the functional role of PD-L1/PD1 targeting in immune cell-mediated cytotoxicity.

Hypothesis

It is hypothesized that PD-L1/PD1 has pivotal role on the immune cell-mediated cytotoxicity in colorectal cancer.

Significances: The current study will elucidate the significance of PD-L1/PD1 on chemo-resistance and the effect on immune cells and their functional properties. The study will enhance the understanding on chemotherapy response and immune evasion. The long-term goal is to provide the crucial information on oncoimmunology to improve efficacy of immunotherapy in cancer treatment.

Subjects: Only those patients for whom colorectal cancer is the indicated clinical diagnosis will be recruited in the current study. Possible participants will be patients undergoing tumor resection or endoscopic examination at the Department of Surgery, Prince of Wales Hospital, Shatin, Hong Kong. Specimens will be collected from sixty-eight colorectal cancer patients. The estimated duration for collection of all the necessary samples will be two years. With at least one year of follow-up information, the proposed study should be completed in three years. For the current study, single blood sample (10 ml of peripheral blood in EDTA) will be drawn before the operation or endoscopic session. A small portion of the tumor and non-tumor tissue tissues from resected specimens or biopsy tissues will be collected for histological evaluation, primary culture and for comparison of the genetic and protein components in the blood specimen.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • colorectal cancer patients undergoing resection or endoscopic examination at the Department of Surgery, Prince of Wales Hospital, Shatin, Hong Kong

排除标准

  • patients who do not consent

结局指标

主要结局

Generation of candidate biomarkers PD-L1/PD1/GEP by laboratory assay qPCR for prognostication.

时间窗: Three years.

Biomarkers PD-L1/PD1/GEP will be investigated by laboratory assay real-time quantitative PCR. The biomarker levels in tissue specimens and the association with recurrence-free survival will be analyzed for prognostication.

次要结局

未报告次要终点

研究者

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

CHEUNG, Siu Tim

Principal Investigator

Chinese University of Hong Kong

研究点 (1)

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