Predicting Response to Chemotherapy in Colorectal Cancer Via Multi-dimensional Analyses of the Tumor Associated Neutrophils

Zhongshan Hospital，Fudan University

A single biomarker is not adequate to identify patients with colorectal cancer (CRC) who have the potential to benefit from adjuvant therapy, presumably owing to the complexity of tumor-infiltrating immune cells (TIICs). The density and spatial organization of TIICs has not been definitely established to explore their predictive value. This study aimed to investigate the prognostic significance of TIICs and its biological predictive value in CRC.

Study Overview

• Status: Completed
• Conditions: Tumor Associated Neutrophils
• Intervention / Treatment: Other: No different intenvention

• Study Type: Observational
• Enrollment (Actual): 653

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study enrolled multiple cohorts, consisting of 653 tumor microarray specimens of CRC patients from Zhongshan Hospital

Description

Inclusion Criteria:

1. Voluntarily sign a written ICF.
2. The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.
3. The expected survival period is ≥ 3 months.

5. Subjects diagnosed with metastatic colorectal adenocarcinoma by histology or cytology.

6. Colorectal cancer patients who have not received systematic anti-tumor therapy in the past.

Exclusion Criteria:

1. Subjects suffered from other malignant tumors within 3 years before enrollment, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.).
2. Simultaneously enroll in another clinical study, unless it is an observational, non-interference clinical study or a follow-up period of an intervention study.
3. Received systematic anti-tumor therapy (chemotherapy) within 3 weeks prior to the first administration

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
response cohort; CRC patients with response status after chemotherapy	Other: No different intenvention; No different intenvention
resistance cohort; CRC patients with resistance status after chemotherapy	Other: No different intenvention; No different intenvention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months	From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2010
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: TANs for CT response in CRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No