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

Huazhong University of Science and Technology

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT03573791

WHUHGE-R01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

152 participants in 2 patient groups

Complete response

Description:

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

Description:

After neoadjuvant therapy, postoperative pathological examination will be performed to evaluate the efficacy of the therapy. Define postoperative staging \>ypT1-2N0 as poor response.