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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

152 Participants
are grouped into 2 trial groups
Group A: Complete response
Group B: Poor response

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

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