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

Recruiting

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

• Registration Number: NCT03573791
• Lead Sponsor: Wuhan Union Hospital, China

Brief Summary

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.

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 Timeline

• Study Start: 2018-05-21
• Study First Submitted: 2018-06-20
• Study First Submitted QC: 2018-06-20
• Study First Posted: 2018-06-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2026-05-21
• Study Completion: 2027-05-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 152

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparing gene expression differences between poor response group and complete response group by using RNA sequencing.	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.

Secondary Outcome Measures

Name	Time	Method
Overall survival(OS)	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.
Progression Free Survival(PFS)	3 years	The time period that from participants joining the groups to the progression of disease(recurrence or metastasis) or death of any cause.

Trial Locations

Locations (2)

Hubei Cancer Hospital; 🇨🇳 Wuhan, Hubei, China

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China