The goal of this observational study is to establish a dynamic multi-omics integration model for predicting pathological complete response (pCR) after neoadjuvant treatment in locally advanced (T3-4NxM0) rectal cancer, providing support for subsequent patient selection for the watch-and-wait strategy. The main question it aims to answer is:
What is the predictive value of this model to assess individual achievement of pathological complete response (pCR) after neoadjuvant treatment? Eligible patients will be prospectively enrolled, and the clinical features of their pre-neoadjuvant treatment, during-treatment, and post-treatment preoperative will be collected and annotated.
Histologically confirmed rectal adenocarcinoma;
Clinical stage T3-4NxM0, with or without positive Mesorectum Fascia(MRF), and with or without positive Extra-Mural Venous Invasion(EMVI);
Preoperative staging method: All patients undergo preoperative staging with enhanced CT. Criteria for mesorectal lymph node metastasis: Short axis ≥ 10mm lymph nodes or lymph node morphology and CT characteristics consistent with typical lymph node metastasis. Preoperative chest, abdominal CT, and pelvic MRI exclude distant metastases;
Absence of signs of intestinal obstruction; or relief of obstruction after proximal colon diversion surgery;
Patients requiring antiarrhythmic therapy (excluding β-blockers or digoxin), symptomatic coronary artery disease, recent myocardial infarction within the past 6 months, or congestive heart failure exceeding New York Heart Association(NYHA) class II;
Poorly controlled severe hypertension;
History of HIV infection or active chronic hepatitis B or C (high viral DNA load);
Active pulmonary tuberculosis (TB) or receiving anti-TB treatment, or having received anti-TB treatment within the past year;
Patients are pathological confirmed as rectal adenocarcinoma, clinical stage T3-4NxM0, and underwent the neoadjuvant therapy before surgical treatment.
Other
Prospective
Medical examination
Other interventionEligible patients will be prospectively enrolled, and images of their pre-neoadjuvant treatment, during-treatment, and post-treatment preoperative magnetic resonance imaging (MRI) scans, histopathology slides stained with hematoxylin and eosin (H\&E), carcinoembryonic antigen (CEA), and circulating tumor DNA (ctDNA) will be collected and annotated.
Area under curve(AUC)
Area under curve of prediction model
Sensitivity
Sensitivity of prediction model
Specificity
Specificity of prediction model
Negative predictive value(NPV)
negative predictive value of prediction model
Positive predictive value(PPV)
positive predictive value of prediction model
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