Personalized blood ctDNA-MRD multi-omics test to predict neoadjuvant therapy response in rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, prospective observational study enrolls patients with locally advanced rectal cancer and collects tumor tissue and serial blood samples at multiple time points around neoadjuvant therapy and surgery. Researchers will analyze plasma ctDNA somatic mutations, copy number variations, and mitochondrial DNA to build a multi-omics molecular biomarker system for MRD detection. The primary aim is to validate the sensitivity and specificity of the combined multi-omics model for predicting pathological response and to compare performance of individual omics features versus their combination. Secondary aims include creating a dynamic model of tumor burden during treatment and optimizing ctDNA-MRD detection methods to reduce sample volume requirements.

Why it matters

Who can join: the full rules

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, or clinically significant supraventricular or ventricular arrhythmia that remains poorly controlled without or despite clinical intervention
* 6: Diagnosis of another malignancy within 5 years prior to the first use of the study drug, except for malignancies with low risk of metastasis or death (5-year survival rate \>90%), such as adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix, which may be considered for inclusion
* 7: Pregnant or lactating women
* 8: Other factors, as judged by the investigator, that may lead to premature termination of the study, such as other severe diseases (including psychiatric disorders) requiring concomitant treatment, alcohol abuse, drug abuse, family or social factors, or any condition that may affect the safety or compliance of the participant

Where it's running

• Beijing Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Yao Hongwei Professor, Doctoral Degree
• Email: yaohongwei@ccmu.edu.cn
• Phone: 13611015609

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.