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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03573791
• Other study ID #: WHUHGE-R01
• Status: Recruiting
• Start date: May 21, 2018
• Est. completion date: May 21, 2026

Study information

• Verified date: December 2023
• Source: Wuhan Union Hospital, China
• Contact: Zheng Wang, MD/PhD
• Phone: +86 27 85726612
• Email: zhengwang[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: May 21, 2026
• Est. primary completion date: May 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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 ?-? 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.

Related Conditions & MeSH terms

• Cancer of Rectum
• Cancer of the Rectum
• Neoplasms
• Neoplasms, Rectal
• Rectal Cancer
• Rectal Neoplasms
• Rectal Tumors
• Rectum Cancer
• Rectum Neoplasms

Locations

Country	Name	City	State
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Wuhan Union Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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