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Clinical Trials/NCT04051450
NCT04051450
Unknown
Not Applicable

Immune Checkpoints in Colorectal Cancer

Chinese University of Hong Kong1 site in 1 country68 target enrollmentMay 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Chinese University of Hong Kong
Enrollment
68
Locations
1
Primary Endpoint
Generation of candidate biomarkers PD-L1/PD1/GEP by laboratory assay qPCR for prognostication.
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2020
End Date
May 1, 2024
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

CHEUNG, Siu Tim

Principal Investigator

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • patients who do not consent

Outcomes

Primary Outcomes

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

Time Frame: 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.

Study Sites (1)

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