Rectal Cancer
Conditions
Keywords
Rectal cancer, Real world study, Neoadjuvant Therapy
Brief 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.
Detailed description
1. Optimisation and predictive modelling of immunotherapy combined with neoadjuvant chemoradiotherapy Through real-world studies, we will evaluate the efficacy and safety of immunotherapy combined with neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer, focusing on comparing outcomes with traditional chemoradiotherapy regimens to optimise neoadjuvant treatment protocols. By integrating radiomics and molecular subtyping data, we will develop a deep learning model to predict the rate of pathological complete response, thereby accurately forecasting treatment outcomes for patients. This model can further optimise personalised treatment decisions, enhance the effectiveness of organ-preservation strategies, and ultimately reduce surgical trauma for patients. 2. A Treatment Efficacy Assessment System Combining Multi-omics Data with Artificial Intelligence Integrate multi-omics data (such as molecular subtyping, radiomics, and pathological assessment) with artificial intelligence technology to establish a treatment efficacy assessment system. Utilise deep learning models to analyse pre- and post-treatment imaging data and pathological samples, thereby achieving precise efficacy assessment.
Interventions
OTHERThis study is a multicenter, real-world, non-interventional study.
non-interventional study
Sponsors
Beijing Friendship Hospital
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety profile | 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). |
| Therapy Tolerability | 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. |
| Disease-Free Survival (DFS) | 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. |
Countries
China
Contacts
CONTACThongwei Yao, Professor, Doctoral Degree
Outcome results
None listed