Personalized blood ctDNA-MRD multi-omics test to predict neoadjuvant therapy response in rectal cancer
Application and Exploration of Personalized ctDNA-MRD Detection Technology in Predicting the Efficacy of Neoadjuvant Therapy for Rectal Cancer
Beijing Friendship Hospital · NCT07393048
This project will test whether a personalized blood-based ctDNA-MRD multi-omics test can predict how well neoadjuvant therapy works for people with locally advanced rectal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Beijing Friendship Hospital (other) |
| Drugs / interventions | tislelizumab, chemotherapy, immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07393048 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–75 with histologically confirmed locally advanced rectal adenocarcinoma (clinical stage II–III) who are treatment‑naïve, planned for neoadjuvant therapy followed by surgery, and able to provide serial blood and tissue samples.
Not a fit: Patients with prior antitumor therapy, distant metastases, inability to provide serial samples, or who cannot attend the single study site are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the test could help tailor treatment by identifying who is responding to neoadjuvant therapy and who may need treatment changes before surgery.
How similar studies have performed: ctDNA‑based MRD approaches have shown promise in colorectal cancer for detecting residual disease and predicting recurrence, but combining ctDNA mutations, copy number variation, and mtDNA to predict neoadjuvant response in rectal cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- Beijing Friendship Hospital — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Yao Hongwei Professor, Doctoral Degree
- Email: yaohongwei@ccmu.edu.cn
- Phone: 13611015609
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Locally Advanced Rectal Cancer, ctDNA-MRD, Rectal Cancer, Neoadjuvant Therapy, Predicting the Efficacy, Detection Technology