NCT07566559Recruiting
Rectal Cancer Neoadjuvant Therapy-Real World Study
Establishing a Strategy for Selecting Watchful Waiting and Determining the Optimal Timing for Surgery Following Neoadjuvant Therapy
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
This study aims to utilise a real-world data platform to integrate multi-omics data-including radiomics, gut microbiota, pathological quality control and liquid biopsy-to construct a multidimensional predictive model for the efficacy of rectal cancer treatment following neoadjuvant therapy. By integrating multimodal data, the study aims to accurately assess the efficacy of neoadjuvant therapy and identify patients suitable for a 'watch-and-wait' strategy, thereby achieving tumour control and preserving organ function without the need for surgery. Furthermore, it seeks to provide scientific evidence for the efficacy of the 'watch-and-wait' strategy and the selection of optimal timing for surgery, whilst validating the model's effectiveness and assessing its clinical feasibility through prospective clinical trials.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 869 (estimated)
- First submitted
- 20 Apr 2026
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Beijing Friendship Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07566559
What you commit to
- Study type: Observational
- Planned participants: 869
- From 1 Jan 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Multiple primary colorectal cancers;
- History of prior malignancy (except completely cured carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin).
Other
- Presence of distant organ metastasis;
Who the study is looking for
- The patient is informed and has provided written informed consent;
- Rectal adenocarcinoma confirmed by colonoscopic biopsy and pathology, meeting the following criteria:
- Clinical stage II/III locally advanced rectal cancer (LARC): cT1-4aN0-2M0;
- The distal edge of the tumor is ≤ 10 cm from the anal verge (measured by MRI);
- No distant metastasis;
- Scheduled to receive neoadjuvant therapy;
- Age ≥ 18 years, male or female。
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.