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Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer

Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer

Recruiting
18-75 years
All
Phase N/A

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Overview

Neoadjuvant therapy has been widely applied to locally advanced rectal cancer. However, about 50% of patients receiving this therapy do not respond well as evidenced by the fact that their T or N stages are not effectively decreased judged by postoperative pathological examination. The purpose of this trail is to identify the biomarkers (from within patients' tumor mass before neoadjuvant therapy) to predict resistance to neoadjuvant therapy. These biomarkers can help stratify neoadjuvant-resistant patients towards surgery while avoiding unnecessary chemoradio-based neoadjuvant therapy.

Description

According to postoperative pathological examination results, all participants will be divided into two groups: complete response (ypT0N0) and poor response (>ypT1-2N0). Differentially expressed genes between complete response and poor response will be analyzed. A scoring formula will be established based on the results. Tumor tissue samples are collected before neoadjuvant therapy and will be analyzed via RNA sequencing.

Eligibility

Inclusion Criteria:

  • Histopathology proved to be adenocarcinoma of the rectum.
  • The edge of tumor is within 12cm of anus margin.
  • According to the eighth edition of AJCC TNM staging standard ,that staging for Ⅱ-Ⅲ period, as T3-T4, N0 or any T, N1-2.
  • There is no history of chemotherapy, radiotherapy or immunotherapy before neoadjuvant therapy.
  • Understand and agree to sign the informed consent for the study.

Exclusion Criteria:

  • With intestinal obstruction or impending obstruction, or perforation.
  • With other malignancies occurred within 5 years.

Study details
    Rectal Cancer
    Cancer of Rectum
    Cancer of the Rectum
    Neoplasms
    Rectal
    Rectal Tumors
    Rectum Cancer
    Rectum Neoplasms

NCT03573791

Wuhan Union Hospital, China

25 January 2024

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