Predicting Pathological Complete Response in Rectal Cancer Using Machine Learning

Peking University

Status: Active, not recruiting

Conditions: Neoadjuvant Chemoradiotherapy; Rectal Cancers; Machine Learning; Pathological Complete Response

Treatments: Diagnostic Test: No interventions

Study type: Observational

Funder types: Other

Identifiers

NCT07509632

2026PHB131-001

Details and patient eligibility

About

This study aims to develop and validate a robust machine learning-based prediction model utilizing baseline clinical data and magnetic resonance imaging (MRI) features. The objective is to preoperatively predict the probability of achieving a pathological complete response (pCR) in patients with locally advanced rectal cancer (CRC) following neoadjuvant chemoradiotherapy (nCRT).

Full description

This study aims to develop and validate a predictive model based on pre-neoadjuvant clinical, laboratory, and magnetic resonance imaging (MRI) features to estimate the probability of pathological complete response (pCR) in rectal cancer patients after neoadjuvant chemoradiotherapy (nCRT). This retrospective study will enroll patients who received nCRT followed by radical resection at Peking University People's Hospital between December 2017 and October 2025 as the development cohort. Least Absolute Shrinkage and Selection Operator (LASSO) regression will be used for feature selection, and machine learning algorithms will be applied to construct the prediction model. Model performance will be comprehensively evaluated using the receiver operating characteristic (ROC) curve, precision-recall curve, calibration curve, and decision curve analysis (DCA). SHapley Additive exPlanations (SHAP) analysis will be performed to enhance model interpretability. The final model is expected to provide an individualized pCR prediction tool to guide clinical decision-making for rectal cancer patients.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with histopathologically confirmed rectal adenocarcinoma;
2. Clinical stage cT3-4, or cN+, or M1 advanced rectal cancer;
3. Received standardized neoadjuvant chemoradiotherapy or neoadjuvant chemotherapy;
4. Underwent total mesorectal excision (TME) after the completion of neoadjuvant therapy, with complete postoperative pathological data available.

Exclusion criteria

1. Previous history of other malignant tumors;
2. Incomplete clinical data;
3. Underwent emergency surgery during nCRT;
4. Complicated with systemic infection or hematological diseases.