Identifying biomarkers to predict resistance to neoadjuvant therapy in rectal cancer
Official title: Identification of Tissue Biomarkers for Predicting Neoadjuvant Chemoradio-resistance in Patients With Middle-low Local Advanced Rectal Cancer.
Run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · NCT03573791 · Data updated 2026-11-12
This study is trying to find markers in tumor samples from patients with advanced rectal cancer to see if they can predict who will not benefit from a specific treatment before it starts.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 152 (estimated) |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (Wuhan, Hubei and 1 other locations) |
| Status | Recruiting |
| Started | May 21, 2018 |
| Main results expected | May 21, 2027 |
| Study ends | May 21, 2028 |
| Registry record updated | August 18, 2026 |
| Trial ID | NCT03573791 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients diagnosed with adenocarcinoma of the rectum, staged II-III, who have not undergone prior chemotherapy, radiotherapy, or immunotherapy.
✕Probably not a fit
Patients with intestinal obstruction, perforation, or other malignancies within the past five years may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to identify biomarkers from tumor samples of patients with middle-low advanced rectal cancer to predict their resistance to neoadjuvant chemoradiotherapy. By analyzing differentially expressed genes between patients who respond well and those who do not, the researchers will develop a scoring formula to help stratify patients. This approach seeks to avoid unnecessary treatment for patients unlikely to benefit from neoadjuvant therapy. Tumor tissue samples will be collected prior to treatment and analyzed using RNA sequencing.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment plans for rectal cancer patients, improving outcomes and reducing unnecessary therapies.
How similar studies have gone: While the approach of identifying biomarkers for treatment resistance is gaining traction, this specific study's methodology is relatively novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Wuhan Union Hospital
Wuhan, Hubei, China Recruiting -
Hubei Cancer Hospital
Wuhan, Hubei, China Not yet recruiting
Study contacts
- Study coordinator: Zheng Wang, MD/PhD
- Email: zhengwang@hust.edu.cn
- Phone: +86 27 85726612
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.