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

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: Rectal Cancer; Cancer of Rectum; Cancer of the Rectum; Rectum Cancer; Rectum Neoplasms; Neoplasms, Rectal; Rectal Tumors

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

• 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

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

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.	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)	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)	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

• Sponsor: Wuhan Union Hospital, China
• Investigators: Study Chair: Zheng Wang, MD/PhD, Wuhan Union Hospital, China

Publications and helpful links

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

Study Major Dates

• Study Start (Actual): May 21, 2018
• Primary Completion (Estimated): May 21, 2026
• Study Completion (Estimated): May 21, 2027

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: WHUHGE-R01

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