This study is a multicenter, real-world, non-interventional study.
This study is a multicenter, real-world, non-interventional study.: non-interventional study
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* The patient is informed and has provided written informed consent;
* Rectal adenocarcinoma confirmed by colonoscopic biopsy and pathology, meeting the following criteria:
1. Clinical stage II/III locally advanced rectal cancer (LARC): cT1-4aN0-2M0;
2. The distal edge of the tumor is ≤ 10 cm from the anal verge (measured by MRI);
3. No distant metastasis;
4. Scheduled to receive neoadjuvant therapy;
* Age ≥ 18 years, male or female。
Exclusion Criteria:
* 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).
Primary outcome measure(s)
To compare the complete response rates across different treatments. — Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion) Compare the complete response rates (including pathological complete response \[pCR\] and clinical complete response \[cCR\]) between a neoadjuvant regimen combining chemoradiotherapy with immunotherapy and the traditional neoadjuvant chemoradiotherapy regimen, in patients with locally advanced rectal cancer.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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