Rectal Cancer Neoadjuvant Therapy-Real World Study
Recruiting now
Conditions studied: Rectal Cancer
In brief
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.
Key facts
- Study ID
- NCT07566559
- Run by
- Beijing Friendship Hospital
- People needed
- 869
- Starts
- 2025-01-01
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-05-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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。
You may not qualify if…
- Presence of distant organ metastasis;
- 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).
Where it is running
- Beijing Friendship Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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