Application and Exploration of Personalized ctDNA-MRD Detection Technology in Predicting the Effi… (NCT07393048) | Clinical Trial Compass
RecruitingNot Applicable
Application and Exploration of Personalized ctDNA-MRD Detection Technology in Predicting the Efficacy of Neoadjuvant Therapy for Rectal Cancer
China60 participantsStarted 2026-02-15
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 1: Signed a written informed consent form and voluntarily participated in this study
* 2: Aged 18-75 years, regardless of sex
* 3: Histopathologically confirmed rectal adenocarcinoma
* 4: Clinical stage II-III as assessed by MRI (according to the AJCC 8th edition)
* 5: Distance from the lower tumor margin to the anal verge ≤10 cm
* 6: Surgically resectable
* 7: Able to swallow tablets normally
* 8: ECOG PS 0-1
* 9: No prior antitumor therapy for rectal cancer, including radiotherapy, chemotherapy, or surgery
* 10: Scheduled to undergo surgical treatment after completion of neoadjuvant therapy
* 11: No surgical contraindications
* 12: Normal function of major organs, including: complete blood count, blood biochemistry, and coagulation function
Exclusion Criteria:
* 1: History of allergy to monoclonal antibodies, any component of tislelizumab, or capecitabine
* 2: Prior or ongoing receipt of any tumor-directed surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc
* 3: Presence of any active autoimmune disease or history of autoimmune disease
* 4: History of immunodeficiency, including a positive HIV test result, other acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation
* 5: Poorly controlled cardiac clinical symptoms or diseases, including but not limited to: heart failure of NYHA class II or above, unstable angina, myocardial infarction within the past year…
What they're measuring
1
Complete Response (CR) rate
Timeframe: Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion)