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

August 17, 2026 updated by: Zheng Wang, MD/PhD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Identification of Tissue Biomarkers for Predicting Neoadjuvant Chemoradio-resistance in Patients With Middle-low Local Advanced Rectal Cancer.

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Zheng Wang, MD/PhD
Phone Number: +86 27 85726612
Email: zhengwang@hust.edu.cn

Study Locations

China
- Hubei
  - Wuhan, Hubei, China, 430022
    - Recruiting
    - Wuhan Union Hospital
    - Contact:
      
      Zheng Wang, MD/PhD
      
      Phone Number: +86 27 85726612
      
      Email: zhengwang@hust.edu.cn
  - Wuhan, Hubei, China, 430079
    - Not yet recruiting
    - Hubei Cancer Hospital
    - Contact:
      
      Shengwei Ye, MD/PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

All participants will be recruited from Wuhan Union Hospital or Hubei Cancer Hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Control
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Complete response After neoadjuvant therapy, postoperative pathological examination will be performed to evaluate the efficacy of the therapy. Define postoperative staging ypT0N0 as complete response.
Poor response After neoadjuvant therapy, postoperative pathological examination will be performed to evaluate the efficacy of the therapy. Define postoperative staging >ypT1-2N0 as poor response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing gene expression differences between poor response group and complete response group by using RNA sequencing. Time Frame: 6 months	Using RNA-seq sequencing method to obtain the whole genome transcription profiles of the poor response group and complete response group, and compare the gene expression differences between these two groups.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival(OS) Time Frame: 3 years	The total survival time of the participants from joining the group to the death. If the death time is unknown, the relevant participants will be excluded for analysis.	3 years
Progression Free Survival(PFS) Time Frame: 3 years	The time period that from participants joining the groups to the progression of disease(recurrence or metastasis) or death of any cause.	3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Investigators

Study Chair: Zheng Wang, MD/PhD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Chang GJ, Park IJ, You YN, et al. Neoadjuvant treatment response and outcomes in locally advanced rectal cancer: Establishing oncologic benchmarks. Journal of Clinical Oncology 29(15):3545-3545,2011.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2018

Primary Completion (Estimated)

May 21, 2027

Study Completion (Estimated)

May 21, 2028

Study Registration Dates

First Submitted

June 20, 2018

First Submitted That Met QC Criteria