Application and Exploration of Personalized ctDNA-MRD Detection Technology in Predicting the Efficacy of Neoadjuvant Therapy for Rectal Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorBeijing Friendship Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Personalized ctDNA-MRD Detection

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators