Actively Recruiting
Application and Exploration of Personalized ctDNA-MRD Detection Technology in Predicting the Efficacy of Neoadjuvant Therapy for Rectal Cancer
Led by Beijing Friendship Hospital · Updated on 2026-04-21
60
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-center, prospective, observational clinical trial enrolling patients with locally advanced rectal cancer (cT3-4aN0M0 and cT1-4aN1-2M0). By collecting tissue and blood samples at multiple timepoints, and integrating multi-omics data including ctDNA mutations, copy number variations, and mtDNA profiles, a multi-omics model will be constructed to predict the efficacy of neoadjuvant therapy for rectal cancer.
CONDITIONS
Official Title
Application and Exploration of Personalized ctDNA-MRD Detection Technology in Predicting the Efficacy of Neoadjuvant Therapy for Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed a written informed consent form and voluntarily agreed to participate
- Aged 18 to 75 years, any gender
- Histopathologically confirmed rectal adenocarcinoma
- Clinical stage II-III rectal cancer assessed by MRI according to AJCC 8th edition
- Tumor located within 10 cm from the anal verge
- Tumor is surgically resectable
- Ability to swallow tablets normally
- ECOG performance status of 0 or 1
- No prior antitumor therapy for rectal cancer, including surgery, chemotherapy, or radiotherapy
- Scheduled to have surgery after completing neoadjuvant therapy
- No contraindications for surgery
- Normal major organ function, including blood counts, biochemistry, and coagulation
You will not qualify if you...
- History of allergy to monoclonal antibodies, tislelizumab, capecitabine, or their components
- Prior or ongoing tumor-directed treatments including surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy
- Active or past autoimmune diseases
- Immunodeficiency conditions including positive HIV, organ transplantation, or bone marrow transplantation
- Poorly controlled cardiac conditions such as NYHA class II or higher heart failure, unstable angina, recent myocardial infarction, or significant arrhythmia
- Diagnosis of another cancer within 5 years except for low-risk skin cancers or cervical carcinoma in situ
- Pregnant or breastfeeding women
- Other severe conditions or factors that may affect safety or study compliance as judged by the investigator, including psychiatric disorders, substance abuse, or social factors
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
Research Team
Y
Yao Hongwei Professor, Doctoral Degree
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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