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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Hubei Cancer Hospital
NOT_YET_RECRUITING
Wuhan
Wuhan Union Hospital
RECRUITING
Wuhan
Contact Information
Primary
Zheng Wang, MD/PhD
zhengwang@hust.edu.cn
+86 27 85726612
Time Frame
Start Date: 2018-05-21
Estimated Completion Date: 2027-05-21
Participants
Target number of participants: 152
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

This content was sourced from clinicaltrials.gov