Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer
Recruiting · NCT03573791 · Observational (researchers observe without assigning treatment) · Lead sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
View the official record on ClinicalTrials.gov →What this trial is 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.
Who can take part
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.
Where it is running
2 locations listed.
- Wuhan Union Hospital - Wuhan, Hubei, China
- Hubei Cancer Hospital - Wuhan, Hubei, China