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

NCT ID: NCT03573791

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-21

Study Completion Date

2027-05-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rectal Cancer Cancer of Rectum Cancer of the Rectum Neoplasms, Rectal Rectal Tumors Rectum Cancer Rectum Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Complete response

After neoadjuvant therapy, postoperative pathological examination will be performed to evaluate the efficacy of the therapy. Define postoperative staging ypT0N0 as complete response.

No interventions assigned to this group

Poor 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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zheng Wang, MD/PhD

Study chair, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zheng Wang, MD/PhD

Role: STUDY_CHAIR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wuhan Union Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, China

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zheng Wang, MD/PhD

Role: CONTACT

+86 27 85726612

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zheng Wang, MD/PhD

Role: primary

+86 27 85726612

Shengwei Ye, MD/PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Chang GJ, Park IJ, You YN, et al. Neoadjuvant treatment response and outcomes in locally advanced rectal cancer: Establishing oncologic benchmarks. Journal of Clinical Oncology 29(15):3545-3545,2011.

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WHUHGE-R01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.