About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
With intestinal obstruction or impending obstruction, or perforation.
With other malignancies occurred within 5 years.
Trial population
All participants will be recruited from Wuhan Union Hospital or Hubei Cancer Hospital.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
Sponsors and contacts
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