Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050, China
Location status: Recruiting
NCT Number: NCT07566559
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.
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All sexes
Observational
Beijing, Beijing Municipality, 100050, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
non-interventional study
Time frame: 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.
Time frame: 20 weeks after the first radiotherapy session
Adverse Events (AEs): Type, incidence, severity, and relationship to the study treatment. Severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0).
Time frame: 20 weeks after the first radiotherapy session
The proportions of patients with dose interruption, dose reduction, and treatment discontinuation during the neoadjuvant treatment period, all due to treatment-related toxicity.
Time frame: within 5 years after completion of neoadjuvant therapy
Disease-Free Survival (DFS) is a key endpoint (a measure of outcome) used primarily in oncology clinical trials, especially for evaluating adjuvant or curative treatments.
Time frame: within 5 years after completion of neoadjuvant therapy
Overall Survival (OS) is the primary and most objective endpoint in oncology clinical trials. It measures the time from a defined starting point (e.g., date of diagnosis, randomization in a trial, or start of treatment) until death from any cause.
Contact information is provided by the study sponsor or research team.
Beijing Friendship Hospital
Other
Establishing a Strategy for Selecting Watchful Waiting and Determining the Optimal Timing for Surgery Following Neoadjuvant Therapy
Acronym: RC-NAT-RWS
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