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NCT Number: NCT03573791

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

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.

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Key information

Conditions

Rectal Cancer Cancer of Rectum Cancer of the Rectum Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Neoplasms, Rectal Rectal Diseases Rectal Neoplasms Rectal Tumors Rectum Cancer Rectum Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hubei Cancer Hospital, Wuhan, Hubei, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Comparing gene expression differences between poor response group and complete response group by using RNA sequencing.

    Time frame: 6 months

    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

  1. Overall survival(OS)

    Time frame: 3 years

    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.

  2. Progression Free Survival(PFS)

    Time frame: 3 years

    The time period that from participants joining the groups to the progression of disease(recurrence or metastasis) or death of any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Zheng Wang, MD/PhD

CONTACT

[email protected]

+86 27 85726612

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2027
First posted
Jun 29, 2018
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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