An observational study in Rectal Cancer, Cancer of Rectum and Cancer of the Rectum, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Observational
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.
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.
All participants will be recruited from Wuhan Union Hospital or Hubei Cancer Hospital.
Exclusion Criteria:
After neoadjuvant therapy, postoperative pathological examination will be performed to evaluate the efficacy of the therapy. Define postoperative staging ypT0N0 as complete 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.
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.
Time frame: 6 months
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.
Time frame: 3 years
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.
Time frame: 3 years
Plan to share: No
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology