Actively Recruiting
Dynamic Multi-omics Integration Model to Predict Neoadjuvant Therapy Response in Locally Advanced Rectal Cancer
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-12-18
106
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dynamic Multi-omics Integration Model to Predict Neoadjuvant Therapy Response in Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed rectal adenocarcinoma
- Clinical stage T3-4NxM0, with or without positive Mesorectum Fascia and Extra-Mural Venous Invasion
- Preoperative staging with enhanced CT showing no distant metastases
- No signs of intestinal obstruction or obstruction relieved by proximal colon diversion surgery
- No history of previous colorectal surgery
- No history of previous chemotherapy, radiotherapy, biological therapy, or immunotherapy
- No restrictions on previous hormonal therapy
- Signed informed consent form
You will not qualify if you...
- Need for antiarrhythmic therapy excluding beta-blockers or digoxin, symptomatic coronary artery disease, recent myocardial infarction within 6 months, or heart failure above NYHA class II
- Poorly controlled severe hypertension
- History of HIV infection or active chronic hepatitis B or C with high viral load
- Active pulmonary tuberculosis or recent anti-TB treatment within 1 year
- Other severe active infections
- Evidence of distant metastases outside the pelvis before surgery
- Cachexia or organ failure
- History of pelvic or abdominal radiotherapy
- Multifocal colorectal cancer
- Need for epilepsy management with steroids or antiepileptic drugs
- History of other cancers within 5 years except cured cervical carcinoma in situ or basal cell skin carcinoma
- Substance abuse or medical, psychological, or social conditions interfering with study participation
- Active or history of autoimmune disease except resolved childhood asthma or vitiligo
- Vaccination with anti-infective vaccines within 4 weeks before enrollment
- Long-term immunosuppressive or corticosteroid use above specified doses
- Known or suspected allergy to study-related medications
- Any unstable condition risking patient safety or compliance
- Pregnancy or lactation without adequate contraception
- Refusal to sign informed consent form
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Sixth Affiliated Hospital, Sun Yatsen University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
J
Jun Huang
CONTACT
M
Meijin Huang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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