About this trial
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.
Eligibility criteria
Qualifiers
The patient is informed and has provided written informed consent;
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;
Disqualifiers
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).
Trial design
Treatments tested in this trial
- This study is a multicenter, real-world, non-interventional study.